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METRON PS-320, FLUKE BIOMEDICAL PS-320
 Request for Information Form |
 Contact Information
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| Company Name | FLUKE BIOMEDICAL |
| Address | 6920 SEAWAY BLVD. |
| City, State, Zip | EVERETT, WA 98203 |
| Country | US |
| FDA Owner/Operator Phone | 425-347-6100 |
| FDA Medical Specialty Code | CV - Cardiovascular |
| FDA Product Code | DRT |
| FDA Classification Name | MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 870.2300 |
| FDA Common Generic Name | FETAL SIMULATOR |
| FDA Proprietary Device Name | METRON PS-320, FLUKE BIOMEDICAL PS-320 |
| FDA Owner / Operator Number | 9031860 |
| FDA Owner / Operator Name | FLUKE ELECTRONICS CORP. |
| FDA Establishment Registration Number | 2921581 |
| FDA Registered Establishment Name | FLUKE BIOMEDICAL |
| FDA Operation Code(s) |
MS - Specification Developer RR - Repackager/Relabeller |
| FDA Listing Date | 06-09-06 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of FLUKE BIOMEDICAL
Our records indicate that the following medical device companies may manufacture a similar device.| Company Name / Address / Phone | Proprietary Device Name | Common Generic Device Name | |
| 1 | ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471 |
MULTIPLE | VARIOUS TYPES |
| 2 | ACCUSYNC MEDICAL RESEARCH CORP. 132 RESEARCH DR. MILFORD, CT 06460 US 203-877-1610 / 203-877-1610 |
CARDIAC MONITOR | CARDIAC MONITOR |
| 3 | ACUMEN, INC. 101A EXECUTIVE DR., SUITE 200 STERLING, VA 20166 US 800-852-7823 / 703-904-0405 227 |
MULTIPLE | VARIOUS MODELS OF WIRELESS HEART RATE MONITORS |
| 4 | AEROTEL MEDICAL SYSTEMS (1998) LTD. 5 HATZOREF ST. HOLON, 58856 IS 972-355-93222 / 201-727-1303 |
HEART 2002P | ECG EVENT RECORDER |
| 5 | ALEXANDER TECHNOLOGIES 1511 SOUTH GARFIELD PL. MASON CITY, IA 50401 US 641-423-8955 / 641-421-5837 |
BATTERY PACKS ONLY | |
| 6 | ANALOGIC CORP. 8 CENTENNIAL DR. PEABODY, MA 01960 US 978-326-4000 / 978-326-4619 |
LIFEGARD A3 | CARDIAC MONITOR |
| 7 | APPLIED CARDIAC SYSTEMS 22912 EL PACIFICO DR. LAGUNA HILLS, CA 92653 US 714-855-9366 / 949-855-9366 |
HOLTER PERFORMER RECORDER | HOLTER RECORDER |
| 8 | APPLIED SCIENCE GROUP, INC. 175 MIDDLESEX TURNPIKE BEDFORD, MA 01730 US 781-275-4000 / 781-275-4000 |
MULTIPLE | VARIOUS MODELS OF PULSE RATE MONITORS |
| 9 | ASTI-AS TRONDELAG INDUSTRIELEKTRONIKK OYBERGVEIEN 15 SELBU, N-7580 NO 47-73-810081 / 47-73-810081 |
METRON,PS-320,FLUKE BIOMEDICAL PS-320 | FETAL SIMULATOR |
| 10 | BIOCARE ASIA CORPORATION LTD. NO. 69 HUANGPU STREET NEW DISTRICT SUZHOU, JIANGSU, 215011 CH 86-512-6809-1772 / 86-512-68091772 |
507 VITAL SIGNS MONITOR | VARIOUS MODELS OF 507 VITAL SIGNS MONITORS |
| 11 | BIOCARE CORP. 2F. NO. 25 R&D RD. II SCIENCE-BASED INDUSTRIAL PARK HSINCHU, 300 TW 886-357-81410x6222 / 886-357-81410x6222 |
507 VITAL SIGNS MONITOR, 506 PATIENT MONITORS | VARIOUS MODELS OF 507 VITAL SIGNS MONITOR, VITAL SIGNS MONITOR |
| 12 | BIOSENSOR RESEARCH INSTITUTE OF AMERICA INC. 11545 LAKELAND DR. NORTH SUITE 101 MAPLE GROVE, MN 55369 US 763-425-4555 / 612-310-5246 |
ANXIETY ALARM | SLEEP ALARMS |
| 13 | CARDIAC SCIENCE CORPORATION, MANUFACTURING AND DIS 500 BURDICK PKWY. DEERFIELD, WI 53531 US 425-402-2000 / 425-402-2255 |
MULTIPLE | STRESS MONITOR |
| 14 | CODISOFT, INC. 315 BOBOS PLAZA 996-4 YEONGTONG-DONG, YEONTONG-GU SUWON-SI, GYEONGGI-DO, 443-813 KS 31-205-9341 / 909-980-9933 |
HIMS M100-D (IMPROVEMENT) MANAGEMENT SYSTEM | CARDIAC MONITOR |
| 15 | CRITICARE SYSTEMS, INC. 20925 CROSSROADS CIRCLE WAUKESHA, WI 53186 US 262-798-5361 / 262-798-5361 |
507 VITAL SIGNS MONITOR | VITAL SIGNS MONITOR (VARIOUS MODELS) |
| 16 | DATASCOPE CORP., PATIENT MONITORING DIVISION 800 MACARTHUR BLVD. MAHWAH, NJ 07430 US 201-391-8100 / 201-995-8169 |
MULTIPLE:PASSPORT,PASSPORT 5L,PASSPORT 5L-CE,PASSPORT XG,3000A | MULTIPLE:PASSPORT,PASSPORT 5L,PASSPORT 5L-CE,PASSPORT XG,3000A |
| 17 | DIGICARE BIOMEDICAL TECHNOLOGY, INC. 107 COMMERCE RD. BOYNTON BEACH, FL 33426 US 561-689-0408 / 561-689-0408 |
CARDIOTRACE CT900 | CARDIAC MONITOR |
| 18 | DRAEGER MEDICAL SYSTEMS, INC. 16 ELECTRONICS AVE. DANVERS, MA 01923 US 215-660-2078 / 215-660-2078 |
PATIENT MONITORS, VARIOUS MODELS | MULTIPLE |
| 19 | ELECTRONIC DESIGN & RESEARCH CO., INC. 7331 INTERMODAL DR. LOUISVILLE, KY 40258 US 502-433-8660 / 800-336-1337 |
NO PROPRIETARY NAME LISTED | NO COMMON NAME LISTED |
| 20 | ELMED, INC. 60 WEST FAY AVE. ADDISON, IL 60101 US 630-543-2792 / 630-543-2792 |
ELMED/CARDIOLINE | MONITOR, CARDIAC (INC. CARDIOTACHOMETER AND RATE ALARM |
| 21 | EQUILIBRATED BIO SYSTEMS, INC. 22 LAWRENCE AVE., SUITE LL2 SMITHTOWN, NY 11787 US 631-863-3500 / 631-863-3500 |
POLARFAVOR, POLAR BEAT, POLAR REMOTE RECEIVER | HEART RATE MONITOR, WIRELESS |
| 22 | FUKUDA DENSHI CO., LTD. 3-39-4, HONGO, BUNKYO-KO TOKYO, 113 JA / 425-881-7737 |
MULTIPLE | VARIOUS |
| 23 | GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 HELSINKI, FIN-00510 FI 847-277-5002 / 414-721-3945 |
MULTIPLE | VARIOUS PATIENT MONITORS/MODULES/ACCESSORIES |
| 24 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 9900 INNOVATION DR. WAUWATOSA, WI 53226 US 847-277-5002 / 414-721-3945 |
MULTIPLE | 12 LEAD TRANSFORMATION FUNCTION, 12RL |
| 25 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. MILWAUKEE, WI 53223 US 847-277-5002 / 414-721-3945 |
MULTIPLE | 12 LEAD TRANSFORMATION FUNCTION, 12RL |
| 26 | HEALTHCARE TECHNOLOGY LTD. DRAGOON HOUSE, HUSSAR COURT WATERLOOVILLE HAMPSHIRE, P07 7SF UK 442-392-257388 / 442-392-257388 |
CARDIOSPORT | PULSE RATE WATCH |
| 27 | HEART RATE, INC. 3190-E AIRPORT LOOP COSTA MESA, CA 92626 US 714-850-9716 / 714-850-9716 |
1-2-3 HEART RATE | HEART RATE MONITOR |
| 28 | HELLIGE GMBH MUNZINGER STR. 3 79111 FREIBURG , GM 497-614-5340 |
SMU, 611 UNIVERSAL | SMU, VICOM, EVO |
| 29 | HOANA MEDICAL, INC. 828 FORT STREET MALL SUITE 620 HONOLULU, HI 96825 US 808-523-1225 / 808-523-1225 |
LG1 MEDICAL VIGILANCE SYSTEM | HEART AND RESPIRATORY RATE ALERT SYSTEM |
| 30 | HOSPIRA, INC. 755 JARVIS DR. MORGAN HILL, CA 95037 US 224-212-4517 / 224-212-4688 |
MULTIPLE | VARIOUS TYPES |
| 31 | INDUSTRIAL & BIOMEDICAL SENSORS CORP. 1377 MAIN ST. WALTHAM, MA 02451 US 781-891-4201 / 781-891-4201 |
CARDIO-TACH | VARIOUS MODELS OF HEART RATE MONITORS |
| 32 | INVIVO CORPORATION 12601 RESEARCH PKWY. ORLANDO, FL 32826 US 425-487-7000 / 978-659-4252 |
OMNI-TRAK 3000 SERIES | ECG MONITOR; PLETHSMOGRAPH |
| 33 | JPI, INC. 1507 SAN VICENTE BLVD. SANTA MONICA, CA 90402 US 310-395-2018 / 310-395-2018 |
PULSE RATE MONITOR | |
| 34 | MARCAL MEDICAL, INC. 1114 BENFIELD BLVD., SUITE H MILLERSVILLE, MD 21108 US 410-987-4001 / 410-987-4001 |
GRASEBY | VARIOUS CARDIAC MONITORS |
| 35 | MEDIANA CO., LTD. WONJU MEDICAL IND. PARK 1650-1 DONGHWA-RI, MUNMAK-EUP WONJU-SI, GANGWON-DO, 220-801 KS 82-33-7425400 / 931-937-8093 |
THE YM5500 PATIENT MONITOR | CARDIAC MONITOR (INCLUDING CARDIOTACHOMENTER & RATE ALARM) |
| 36 | MEDISANA GMBH EISBACHSTRASSE 2 MECKENHEIM, 53340 GM / 800-928-9366 |
MEDISANA CARDIOCHECK | HEART RATE MONITOR, PULSE METER |
| 37 | MENNEN MEDICAL LTD. 4 HAYARDEN ST., YAVNE P.O.BOX 102 REHOVOT, 76100 IS 972-893-23333 / 972-893-23333 |
MULTIPLE | CARDIAC MONITOR AND ACCESSORIES |
| 38 | MRL, INC. A WELCH ALLYN COMPANY 1000 ASBURY DR. NO.17 BUFFALO GROVE, IL 60089 US 847-520-0300 / 315-685-4571 |
PORTA PAK 90 MONITOR | CARDIAC MONITOR |
| 39 | NASIFF ASSOC., INC. 841-1 COUNTY ROUTE 37 CENTRAL SQUARE, NY 13036 US 315-676-2346 / 315-676-2346 |
CARDIO CARD HOLTER SYSTEM | CARDIO CARD HOLTER SYSTEM |
| 40 | NIHON KOHDEN CORP. 31-4 NISHIOCHIAI, 1-CHOME, SHINJUKU-KU TOKYO, 161-8560 JA 81-3-5996-8000 / 81-3-5348-1721 |
LIFE SCOPE PATIENT MONITORS | VARIOUS MODELS |
| 41 | NIHON KOHDEN TOMIOKA CORP. 486 NANOKAICHI TOMIOKA CITY, GUNMA, 370-2343 JA 81-3-5996-8000 / 81-3-5348-1721 |
LIFE SCOPE PATIENT MONITORS | VARIOUS MODELS |
| 42 | NIHON SEIMITSU SOKKI CO., LTD. 2508-13 NAKAGO SHIBUKAWA, GUNMA, 377-0293 JA 81-279-20 2311 / 81-279-20 2311 |
SAME | MONITOR, PLUSE RATE |
| 43 | PACE TECH, INC. 510 GARDEN AVE. NORTH CLEARWATER, FL 33755 US 727-442-8118 / 727-442-8118 |
VITALMAX 800 SERIES, VITALMAX 830 SERIES, MINIPACK 911 SERIE | PULSE RATE MONITOR |
| 44 | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. ANDOVER, MA 01810 US 425-487-7000 / 978-659-4252 |
OMNI-TRAK 3000 SERIES | ECG MONITOR,PLETHSMOGRAPH |
| 45 | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 BOEBLINGEN, D 71034 GM 425-487-7000 / 978-659-4252 |
MULTIPLE | MONITOR, CARDIAC (INCLUDING CARDIOTACHOMETER & RATE ALARM) |
| 46 | PHYSIO-CONTROL, INC. 11811 WILLOWS RD., N.E. REDMOND, WA 98052 US 763-514-4000 / 425-867-4644 |
VARIOUS MODELS OF CARDIAC MONITORS INCL. CARDIOTACHOMETER AND RATE ALARM | |
| 47 | PHYSIO-CONTROL, INC. 3301 MONTE VILLA PARKWAY SUITE 230 BOTHELL, WA 98021 US 763-514-4000 / 425-867-4644 |
MULTIPLE | VARIOUS MODELS OF CARDIAC MONITORS |
| 48 | POLAR ELECTRO KY HAKAMAANTIIE 18 SF-90440 KEMPELE, FI / 201-637-6568 |
NO PROPRIETARY NAME LISTED | NO COMMON NAME LISTED |
| 49 | QRS DIAGNOSTIC, LLC. 14755 27TH AVE.NORTH PLYMOUTH, MN 55447 US 763-559-8492 / 763-559-8492 958 |
HEART TEL | MODIFIED BIOLOG |
| 50 | SENSOR DYNAMICS, INC. 4568 ENTERPRISE ST. FREMONT, CA 94538 US 510-623-1459 / 510-623-1459 |
MULTIPLE | VARIOUS MODELS OF HEART RATE MONITORS |
| 51 | SHENZHEN GOLDWAY INDUSTRIAL, INC. 5F BLDG.10 ,ZHONGXING GONGYE TOWN, CHUANGYE ROAD,NANSHAN DISTRICT ,SHENZHEN ,GUANGDONG, 518054 CH 867-556-068859 / 86-755-26240706 |
GOLDWAY UT 4000 | MULTI-PARAMETER PATIENT MONITOR |
| 52 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD BLDG.A3,HONG HUA LING IND.PARK NORTH, LIU XIAN ROAD,XILI TOWN NANSHAN,SHENZHEN, GUANGDONG, 518055 CH 867-552-6582888 / 516-482-9001 |
PM-8000 PATIENT MONITOR, VARIOUS NAMES AND MODELS | PATIENT MONITOR |
| 53 | SMITHS MEDICAL INTERNATIONAL LTD. COLONIAL WAY WATFORD, HERTS., WD24 4LG UK 114-420-8-458-3232 / 44-192-3475809 |
NO PROPRIETARY NAME LISTED | CARDIAC MONITOR |
| 54 | SPACELABS MEDICAL INC. 5150 220TH AVE SE ISSAQUAH, WA 98029 US 425-657-7200 / 425-657-7200 5970 |
PATIENT MONITORS AND ACCESSORIES | PATIENT MONITORS AND ACCESSORIES |
| 55 | THE ANSAR GROUP, INC. 240 SOUTH EIGHTH ST. PHILADELPHIA, PA 19107 US 215-922-6088 / 215-922-6088 |
ANX 3.0 | RESPIRATORY AND CARDIAC SPECTRAL FREQUENCY SIGNAL MONITOR |
| 56 | WELCH ALLYN PROTOCOL, INC. 8500 S.W. CREEKSIDE PLACE BEAVERTON, OR 97008 US 315-685-4100 / 315-685-4571 |
PROPAO; SIRECUST | VITAL SIGNS MONITOR; PORTABLE CARDIAC MONITOR |
| 57 | WELCH ALLYN, INC. 4341 STATE ST. RD. SKANEATELES FALLS, NY 13153 US 315-685-4100 / 315-685-4571 |
VITAL SIGNS MONITOR | VITAL SIGNS MONITOR |
| 58 | WINMED INSTRUMENTS MFG. CORP. 83-85 CHUNG HSIAO EAST RD., 9TH FL., SEC. 6 TAIPEI, 11504 TW |
MONITOR, PULSE RATE | #909 DIGITAL PULSEMETER |
| 59 | WOOLSTHORPE LLC 4897 WEST WATERS AVE., STE. F TAMPA, FL 33634 US 615-376-9779 / 651-452-8886 |
FLOWAVE 1000, VITAL SIGNS MONITOR | VITAL SIGNS MONITOR |
| 60 | ZOE MEDICAL, INC. 460 BOSTON ST. TOPSFIELD, MA 01983 US 978-887-1410 / 978-887-1408 |
ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM | PATIENT MONITORING SYSTEM |
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