GALIX GBI-3S - LP ECG HOLTER RECORDER MANUFACTURED BY GALIX BIOMEDICAL INSTRUMENTATION, INC.

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GALIX GBI-3S - LP ECG HOLTER RECORDER

Request for Information Form	Contact Information
Company Name	GALIX BIOMEDICAL INSTRUMENTATION, INC.
Address	2555 COLLINS AVE., C-5
City, State, Zip	MIAMI BEACH, FL 33140
Country	US
FDA Owner/Operator Phone	305-534-5905
FDA Medical Specialty Code	CV - Cardiovascular
FDA Product Code	MLO
FDA Classification Name	ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM
FDA Device Classification Code	Standards
FDA Regulation Number	870.2800
FDA Common Generic Name	3 CHANNEL, ECG HOLTER RECORDER FOR V.L.P. ANALYSIS
FDA Proprietary Device Name	GALIX GBI-3S - LP ECG HOLTER RECORDER
FDA Owner / Operator Number	9029552
FDA Owner / Operator Name	GALIX BIOMEDICAL INSTRUMENTATION, INC.
FDA Establishment Registration Number	1063225
FDA Registered Establishment Name	GALIX BIOMEDICAL INSTRUMENTATION, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	08-02-06
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of GALIX BIOMEDICAL INSTRUMENTATION, INC.

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	BRENTWOOD MEDICAL TECHNOLOGY CORP. 3300 FUJITA ST. TORRANCE, CA 90505 US 310-530-5955 / 800-624-8950 7216	IQMARK EZ HOLTER, IQMARK ADVANCED HOLTER	IQMARK DIGITAL HOLTER
2	CARDIAC SCIENCE CORPORATION, MANUFACTURING AND DIS 500 BURDICK PKWY. DEERFIELD, WI 53531 US 425-402-2000 / 425-402-2255	QUINTON AND BURDICK BRAND HOLTER SCANNERS	HOLTER MONITOR AND ANALYSIS SYSTEM
3	CARDIONETICS, LTD. CENTAUR HOUSE ANCELLS BUSINESS PARK FLEET HAMPSHIRE, GU51 2UJ UK 44-125-2761040 / 44-125-2761040	C NET 2100	C NET 2100
4	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. MILWAUKEE, WI 53223 US 847-277-5002 / 414-721-3945	SEER	HOLTER RECORDER
5	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 9900 INNOVATION DR. WAUWATOSA, WI 53226 US 847-277-5002 / 414-721-3945	SEER	HOLTER RECORDER
6	GLOBAL INSTRUMENTATION, LLC 8104 CAZENOVIA RD. MANLIUS, NY 13104 US 315-682-0272 213 / 315-682-0272 213	MATRIX HOLTER SYSTEM	ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM
7	MEDICK HEALTHCARE LTD. 4TH FLOOR, EXCHANGE HOUSE 494 MIDSUMMER BLVD. CENTRAL MILTON KEYNES, MK9 2EA UK 44-190-8255945 / 44-190-8255945	MEDICK MHM200 PERSONAL HEART MONITOR	EVENT MONITOR
8	MEDICOMP, INC. 7845 ELLIS RD. WEST MELBOURNE, FL 32904 US 301-608-9292 / 321-676-0010 149	EPICARDIA PM400/410	EVENT RECORDER
9	MEMTEC CORP. 68 STILES RD. UNIT D SALEM, NH 03079 US 603-893-8080 204 / 603-893-8080 204	MODEL 700	HOLTER RECORDER MODEL 700
10	MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. MILWAUKEE, WI 53224 US 414-354-1600 / 414-354-1600	PORTRAIT (ELI 300) HOLTER	HOLTER SCANNER OR HOLTER ANALYSIS SYSTEM
11	NORAV MEDICAL LTD. 2 HAMADA ST. YOKNEAM, 20692 IS 972-4-9893001 / 972-4-9893001	NORAV HOLTER ANALYSIS SYSTEM, NH300	NORAV HOLTER ANALYSIS SYSTEM, NH300
12	PHILIPS MEDICAL SYSTEMS 1525 RANCHERO CONEJO BLVD SUITE 100 THOUSAND OAKS, CA 91320 US 425-487-7000 / 978-659-4252	MULTIPLE	ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM
13	PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. ANDOVER, MA 01810 US 425-487-7000 / 978-659-4252	MULTIPLE	ELECTROCARDIOGRAPH AMBULATORY W/ANALYSIS
14	WELCH ALLYN, INC. 4341 STATE ST. RD. SKANEATELES FALLS, NY 13153 US 315-685-4100 / 315-685-4571	WELCH ALLYN HOLTER RECORDER, HR 100, HR 300, HR 1200	HOLTER RECORDER