LIFESCREEN APNEA MANUFACTURED BY SPACELABS HEALTHCARE LTD.

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LIFESCREEN APNEA

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	AN - Anesthesiology
FDA Product Code	MNR
FDA Classification Name	VENTILATORY EFFORT RECORDER
FDA Device Classification Code	Standards
FDA Regulation Number	868.2375
FDA Common Generic Name	SLEEP APNEA MONITOR
FDA Proprietary Device Name	LIFESCREEN APNEA
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	ADVANCED BRAIN MONITORING, INC. 2237 FARADAY AVENUE SUITE 100 CARLSBAD, CA 92008 US 760-720-0099 / 760-720-0099	APNEA RISK EVALUATION SYSTEM (ARES)	VENTILATORY MONITOR
2	AGC BIOMEDICAL DEVICES, INC. 1317 4TH AVE. AUBURN, GA 30064 US 678-766-1006 / 678-766-1006	APLAB	SLEEP APNEA SCREENING DEVICE
3	BRAEBON MEDICAL CORP. 120 WALGREEN DR (RR#3) SUITE #1 CARP, ONTARIO, K0A 1L0 CA 613-831-6690 / 613-831-6690	MEDIBYTE	PORTABLE SLEEP DATA RECORDER
4	COGENT TECHNOLOGY LIMITED DOCK LANE, MELTON WOODBRIDGE, SUFFOLK, IP12 1PE UK 44-139-4445511 / 44-139-4445511	EMBLA N7000 SYSTEM	VENTILATORY EFFORT RECORDER
5	COMPUMEDICS LIMITED 30-40 FLOCKHART STREET ABBOTSFORD MELBOURNE, VICTORIA, 3067 AS 61-3-8420 7300 / 613-842-07300 x338	COMPUMEDICS SLEEP MONITORING SYSTEMS	SLEEP ASSESSMENT DEVICE
6	COVIDIEN LP, FORMERLY REGISTERED AS KENDALL 98.6 FAICHNEY DR. WATERTOWN, NY 13601 US 508-261-8587 / 508-261-8587	SUZANNE RECORDER & ACCESSORIES	POLYSOMNOGRAPH RECORDER
7	EB NEURO, S.P.A. VIA PIETRO FANFANI 97/A FLORENCE, 50127 IT 011-390-554565131 / 317-569-9500 103	MULTIPLE	VENTILATORY EFFECT RECORDER
8	EMBLA SYSTEMS, INC. 11001 W. 120TH AVE. SUITE 200 BROOMFIELD, CO 80021 US 716-691-0718141 / 303-962-1786	EMBLA N7000,COMPASS F10 SYSTEM, COMPASS M10 SYSTEM, UNIVERSAL XACTTRACE	VENTILATORY EFFORT RECORDER
9	GREATBATCH INC 1771 EAST 30TH ST. CLEVELAND, OH 44114 US 716-759-5600 / 216-937-2800 229	SLEEPFLO INTEGRATED SLEEP DATA SYSTEM	AIRFLOW SENSORS
10	INDIVIDUAL MONITORING SYSTEMS, INC. 1055 TAYLOR AVE., SUITE 300 BALTIMORE, MD 21286 US 410-296-7723 / 410-296-7723	SLEEPCHECK	APNEA CHECK
11	ITAMAR MEDICAL 2 HA'ESHEL ST. CEASAREA, 38900 IS 972-4-6177000 / 1-800-206-6952	WATCHPAT 100	APNEA MONITOR
12	MEDLINE INDUSTRIES, INC. ONE MEDLINE PL. MUNDELEIN, IL 60060 US 847-837-2759 / 847-837-2759	SLEEPSTRIP DISPOSABLE APNEA RECORDER	DISPOSABLE APNEA RECORDER
13	NELLCOR PURITAN BENNETT (MELVILLE) LTD. 303 TERRY FOX DR., STE 400 KANATA, ONTARIO, K2K 3J1 CA 925-463-4371 / 613-238-1840	SUZANNE	POLYSOMNOGRAPHIC RECORDER
14	NEUROTRONICS, INC. 102 N.E. 10TH AVE., SUITE 5 GAINESVILLE, FL 32601 US 352-372-9955 / 352-372-9955	POLYSMITH	POLYSMITH
15	NIVIS, LLC 1000 CIRCLE 75 PARKWAY SUITE 300 ATLANTA, GA 30339 US 678-202-6800 / 678-202-6800	APLAB	VENTILATORY EFFORT RECORDER
16	PRO-TECH SERVICES, INC. 4338 HARBOUR POINTE BLVD. S.W. MUKILTEO, WA 98275 US 425-322-0300 / 425-322-0300	MULTIPLE	VARIOUS
17	RESMED GERMANY INC. FRAUNHOFERSTRASSE 16 MUNCHEN, D-82152 GM 49-899-90100 / 858-746-2576	MICROMESAM, APNEALINK	BREATHING FREQUENCY MONITOR
18	RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1001 MURRY RIDGE LN. MURRYSVILLE, PA 15668 US 724-387-4559 / 724-387-4559	MULTIPLE	MULTICHANNEL RECORDING SYSTEM
19	S.L.P. LTD. 62 ANILEVITCH ST. TEL-AVIV, 67060 IS 972-3-5371281 / 972-353-71281	SLEEPSENSE SLEEP SENSORS	SLEEP SENSORS
20	S.L.P.,INC. 1121 E. MAIN ST. SUITE 240 ST. CHARLES, IL 60174 US 630-513-7479 11 / 630-513-7479 11	MULTIPLE	VARIOUS TYPES OF SLEEPSENSE SENSORS
21	SAGATECH ELECTRONICS, INC. 9, 1515 HIGHFIELD CRES, SW CALGARY, ALBERTA, T2G 5M4 CA 403-228-4214x234 / 403-228-4214x234	SNORESAT RECORDER	SNORESAT RECORDER
22	SECTOR MEDICAL CORP. 320 NORTHPOINT PKWY. SUITE Q ACWORTH, GA 30102 US 770-975-1384 / 770-975-1384	APLAB	APLAB
23	SLEEP SOLUTIONS, INC. 1525 ATTEBERRY LANE SAN JOSE, CA 95131 US 877-753-3775 / 866-682-9267	SILENT NIGHT	ADULT APNEA RECORDER
24	SNAP LABORATORIES, L.L.C. 5210 CAPITOL DRIVE WHEELING, IL 60090 US 847-777-0000 202 / 847-777-0000 202	APNEA/SNORING SCREENING AND ANALYSIS DEVICE	APNAA/SNORING SCREENING AND ANALYSIS DEVICE
25	SOMNOMEDICS GMBH NONNENGARTEN 8 KIST, 97270 GM / 954-646-3734	SOMNO SCREEN	SLEEP SCREENING DEVICE
26	SUNRISE MEDICAL 100 DEVILBISS DR. SOMERSET, PA 15501 US 800-333-4000 / 814-443-7690	MODEL 8100, RM60 SLEEP RECORDER	SLEEP RECORDER
27	TMI INTEGRATED LOGISTIC TILBURG BV CENTAURUSWEG 123 TILBURG, NOORD BRABANT, 5015 TC NL 31-13-4587000 / 31-13-4587131	EMBLA S4000, EMBLA S7000, EMBLA N7000, EMBLETTA PDS, EMBLETTA, COMPASS M10 SYSTE	PSG AMPLIFIER, PSG RECORDER, XACTTRACE BELT
28	VIASYS HEALTHCARE GMBH LEIBNIZSTRASSE 7 HOECHBERG, 97204 GM 847-689-8410 / 714-919-3247	APNOESCREEN PRO, ALPHA SCREEN PRO	BREATHING FREQUENCY MONITOR
29	VIASYS HEALTHCARE UK LIMITED MANOR WAY OLD WOKING, SURREY, GU22 9JX UK 847-689-8410 / 44-148-3748433	SNORE SENSOR	ACCESSORY TO ELECTROENCEPHALOGRAPH DEVICES
30	VIASYS RESPIRATORY CARE INC 1100 BIRD CENTER DR. PALM SPRINGS, CA 92262 US 610-862-0800 / 760-778-7255	SLEEPSCREEN,APNOESCREEN CARDIO	SCREENING DEVICE FOR CARDIAC MONITORING DURING SLEEP TE