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MULTIPLE
 Request for Information Form |
 Contact Information
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| Company Name | SPACELABS HEALTHCARE LTD. |
| Address | 1 HARFORDE COURT
JOHN TATE ROAD |
| City, State, Zip | HERTFORD, |
| Country | UK |
| FDA Owner/Operator Phone | 425-657-7200 |
| FDA Medical Specialty Code | CV - Cardiovascular |
| FDA Product Code | DSH |
| FDA Classification Name | RECORDER, MAGNETIC TAPE, MEDICAL |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 870.2800 |
| FDA Common Generic Name | VARIOUS TYPES OF RECORDERS |
| FDA Proprietary Device Name | MULTIPLE |
| FDA Owner / Operator Number | 2022906 |
| FDA Owner / Operator Name | SPACELABS HEALTHCARE, INC. |
| FDA Establishment Registration Number | 9611295 |
| FDA Registered Establishment Name | SPACELABS HEALTHCARE LTD. |
| FDA Operation Code(s) |
MS - Specification Developer |
| FDA Listing Date | 12-07-06 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of SPACELABS HEALTHCARE LTD.
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 | ALL-TRONICS MEDICAL SYSTEMS 3289 EAST 55TH ST. CLEVELAND, OH 44127 US 216-429-3000 / 216-429-3000 |
HRV 4000EM ENHANCED SVHS RECORDER | SVHS RECORDER |
| 2 | APPLIED CARDIAC SYSTEMS 22912 EL PACIFICO DR. LAGUNA HILLS, CA 92653 US 714-855-9366 / 949-855-9366 |
HOLTER PERFORMER | HOLTER AMBULATORY ECG RECORDER |
| 3 | BIO-LOGIC SYSTEMS CORP. ONE BIOLOGIC PLAZA MUNDELEIN, IL 60060 US 800-255-3901 / 847-949-5200 267 |
BANKER | BANKER |
| 4 | CARDIAC SCIENCE CORPORATION, MANUFACTURING AND DIS 500 BURDICK PKWY. DEERFIELD, WI 53531 US 425-402-2000 / 425-402-2255 |
HOLTER RECORDER | HOLTER RECORDER |
| 5 | CARDIOCOMM SOLUTIONS, INC. 3060 CEDAR HILL RD., SUITE 201 VICTORIA, B.C., V8T 3J5 CA 250-744-1822 / 250-744-1822x248 |
MULTIPLE | VARIOUS |
| 6 | DATRIX 340 STATE PLACE ESCONDIDO, CA 92029 US 760-480-8874 / 760-480-8874 |
DETRIX, XR300 HOLTER RECORDER | ECG CASSETTE HOLTER RECORDER |
| 7 | ELECTRO MEDICAL EQUIPMENT CO., INC. 12015 INDUSTRIPLEX BLVD. BATON ROUGE, LA 70809 US 225-756-0351 / 225-756-0351 34 |
HOLTERLAT | MULTIPLE |
| 8 | FUKUDA DENSHI CO., LTD. 3-39-4, HONGO, BUNKYO-KO TOKYO, 113 JA / 425-881-7737 |
VARIOUS | MULTIPLE |
| 9 | GALIX BIOMEDICAL INSTRUMENTATION, INC. 2555 COLLINS AVE., C-5 MIAMI BEACH, FL 33140 US 305-534-5905 / 305-534-5905 |
GALIX GBI-3S | 3 CHANNEL, DIGITAL ECG HOLTER RECORDER |
| 10 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 9900 INNOVATION DR. WAUWATOSA, WI 53226 US 847-277-5002 / 414-721-3945 |
MULTIPLE HOLTER TAPE RECORDER | HOLTER TAPE RECORDER |
| 11 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. MILWAUKEE, WI 53223 US 847-277-5002 / 414-721-3945 |
MULTIPLE | HOLTER TAPE RECORDER |
| 12 | GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG ODERSTRASSE 77 TELTOW, 14513 GM 004-933-2839420 / 516-482-9001 |
CARDIOMEM(CM3000) | HOLTER RECORDER |
| 13 | LIFEWATCH SERVICES, INC. O'HARE INTERNATIONAL CENTER II 10255 WEST HIGGINS RD, ST# 110 ROSEMONT, IL 60018 US 972-894-84019 / 847-720-2100 |
VARIOUS | TELEPHONE, ELECTROCARDOGRAPH TRANSMITTER AND RECORD |
| 14 | MEMTEC CORP. 68 STILES RD. UNIT D SALEM, NH 03079 US 603-893-8080 204 / 603-893-8080 204 |
MODEL 700 HOLTER RECORDER | HOLTER RECORDER |
| 15 | MENNEN MEDICAL LTD. 4 HAYARDEN ST., YAVNE P.O.BOX 102 REHOVOT, 76100 IS 972-893-23333 / 972-893-23333 |
MR-5200 FULL DISCLOSURE SYSTEM | MEDICAL USE TAPE RECORDER |
| 16 | MRL, INC. A WELCH ALLYN COMPANY 1000 ASBURY DR. NO.17 BUFFALO GROVE, IL 60089 US 847-520-0300 / 315-685-4571 |
PMC HC1000 | PATIENT MONITORING CONSOLE |
| 17 | NORTHEAST MONITORING, INC. TWO CLOCK TOWER PLACE SUITE 555 MAYNARD, MA 01754 US 978-461-3992 / 978-461-3992 |
MULTIPLE | HOLTER RECORDER |
| 18 | PHILIPS (CHINA) INVESTMENT CO., LTD. 27TH FLOOR, TOWER 1, 218 TIAN MU XI ROAD SHANGHAI, 200070 CH 425-487-7000 / 978-659-4252 |
MULTIPLE | RECORDER, MAGNETIC TAPE, MEDICAL |
| 19 | PHILIPS MEDICAL SYSTEMS 1525 RANCHERO CONEJO BLVD SUITE 100 THOUSAND OAKS, CA 91320 US 425-487-7000 / 978-659-4252 |
MULTIPLE | RECORDER, MAGNETIC TAPE, MEDICAL |
| 20 | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. ANDOVER, MA 01810 US 425-487-7000 / 978-659-4252 |
MULTIPLE | RECORDER, MAGNETIC TAPE, MEDICAL |
| 21 | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 BOEBLINGEN, D 71034 GM 425-487-7000 / 978-659-4252 |
MULTIPLE | RECORDER, MAGNETIC TAPE, MEDICAL |
| 22 | PHYSIO-CONTROL, INC. 11811 WILLOWS RD., N.E. REDMOND, WA 98052 US 763-514-4000 / 425-867-4644 |
VOICE RECORDER | |
| 23 | R & D BATTERIES, INC. 3300 CORPORATE CENTER DR. BURNSVILLE, MN 55306 US 952-890-0629 / 952-890-0629 343 |
MULTIPLE | BATTERY, RECHARGEABLE |
| 24 | ROZINN ELECTRONICS, INC. 71-22 MYRTLE AVE. GLENDALE, NY 11385 US 718-386-5526 / 718-386-5526 |
RZ151 HOLTER RECORDER | RZ151 HOLTER RECORDER |
| 25 | SANBOR CORPORATION 7355 WILLIAM AVENUE ALLENTOWN, PA 18106 US 610-530-8500 / 610-530-8500 |
DETRIX, XR300 HOLTER RECORDER | ECG CASSETTE HOLTER RECORDER |
| 26 | SANBOR XIAMEN, INC. 1603 HESHAN ROAD XIAMEN, FUJIAN, 361009 CH 610-530-8500 / 610-530-8500 |
DETRIX, XR300 HOLTER RECORDER | ECG CASSETTE HOLTER RECORDER |
| 27 | SCHILLER AG ALTGASSE 68 BAAR, ZG, 6341 SZ +41-41-766 4242 / 41-41-7664343 |
MICROVIT MT-100 | ELECTROCARDIOGRAPH HOLTER SYSTEM |
| 28 | SPACELABS MEDICAL INC. 5150 220TH AVE SE ISSAQUAH, WA 98029 US 425-657-7200 / 425-657-7200 5970 |
VARIOUS MAGNETIC TAPE/DISK RECORDERS | VARIOUS MAGNETIC TAPE/DISK RECORDERS |
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