LIFECARD CF 7 DAY MANUFACTURED BY SPACELABS HEALTHCARE LTD.

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LIFECARD CF 7 DAY

Request for Information Form	Contact Information
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	MWJ
FDA Classification Name	ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS)
FDA Device Classification Code	Standards
FDA Regulation Number	870.2800
FDA Common Generic Name	HOLTER RECORDER
FDA Proprietary Device Name	LIFECARD CF 7 DAY
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	BRAEMAR, INC. 1285 CORPORATE CENTER DR. SUITE 150 EAGAN, MN 55121 US 651-286-8620 / 651-286-8620	DL700, DL800 SERIES, DXP1000 SERIES, DL1200 SERIES	HOLTER MONITOR
2	DATRIX 340 STATE PLACE ESCONDIDO, CA 92029 US 760-480-8874 / 760-480-8874	MULTIPLE	VARIOUS
3	ELA MEDICAL S.A. 98-100 RUE MAURICE ARNOUX MONTROUGE, 92120 FR 331-496-55555 / 763-519-9408	MULTIPLE	HOLTER ECG RECORDER
4	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 E.C.G. HOLTER RECORDER
5	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. MILWAUKEE, WI 53223 US 847-277-5002 / 414-721-3945	MULTIPLE	ELECTROCARDIOGRAPH
6	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 9900 INNOVATION DR. WAUWATOSA, WI 53226 US 847-277-5002 / 414-721-3945	MULTIPLE ELECTROCARDIOGRAPH,AMBULATORY	ELECTROCARDIOGRAPH,AMBULATORY
7	GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG ODERSTRASSE 77 TELTOW, 14513 GM 004-933-2839420 / 516-482-9001	CARDIOMEM CM 3000-12	HOLTER MONITOR
8	INOVISE MEDICAL, INC. 10565 SW NIMBUS AVE. SUITE 100 PORTLAND, OR 97223 US 503-431-3800 / 503-431-3837	CARDIOVISE ECG INTERPRETATIVE SOFTWARE	CARDIOVISE ECG INTERPRETATIVE SOFTWARE
9	MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. MILWAUKEE, WI 53224 US 414-354-1600 / 414-354-1600	H12+HOLTER RECORDER	HOLTER RECORDER
10	NORTHEAST MONITORING, INC. TWO CLOCK TOWER PLACE SUITE 555 MAYNARD, MA 01754 US 978-461-3992 / 978-461-3992	MULTIPLE	HOLTER RECORDER
11	PHILIPS MEDICAL SYSTEMS 1525 RANCHERO CONEJO BLVD SUITE 100 THOUSAND OAKS, CA 91320 US 425-487-7000 / 978-659-4252	MULTIPLE	ELECTROCARDIOGRAPH,AMBULATORY WITHOUT ANALYSIS
12	SIGNALIFE, INC. 531 SOUTH MAIN ST. SUITE 301 GREENVILLE, SC 29601 US 864-233-2300 / 864-233-2300	RECOM MODEL 100	AMBULATORY ELECTROCARDIOGRAPH MONITOR
13	SPACELABS MEDICAL INC. 5150 220TH AVE SE ISSAQUAH, WA 98029 US 425-657-7200 / 425-657-7200 5970	ARIA	HOLTER RECORDER
14	SUZUKEN CO., LTD. OGUCHI CENTER 58-1 1 CHOME SOTOTUBO OGUCHI-CHO NIWA-GUN, AICHI, 480-0125 JA 81-52-9506327 / 81-52-9506327	MULTIPLE ELECTROCARDIOGRAPH	ELECTROCARDIOGRAPH