SMART MONITOR 2 MANUFACTURED BY RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP

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SMART MONITOR 2

Request for Information Form	Contact Information
Company Name	RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
Address	1001 MURRY RIDGE LN.
City, State, Zip	MURRYSVILLE, PA 15668
Country	US
FDA Owner/Operator Phone	724-387-4559
FDA Medical Specialty Code	AN - Anesthesiology
FDA Product Code	FLS
FDA Classification Name	MONITOR, APNEA, FACILITY USE
FDA Device Classification Code	Standards
FDA Regulation Number	868.2377
FDA Common Generic Name	MONITOR (APNEA DETECTOR), VENTILATORY EFFORT
FDA Proprietary Device Name	SMART MONITOR 2
FDA Owner / Operator Number	2518422
FDA Owner / Operator Name	RESPIRONICS, INC.
FDA Establishment Registration Number	2518422
FDA Registered Establishment Name	RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	03-14-03
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP

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	ALEXANDER TECHNOLOGIES 1511 SOUTH GARFIELD PL. MASON CITY, IA 50401 US 641-423-8955 / 641-421-5837		BATTERY PACKS ONLY
2	ATLAS RESEARCHES LTD. POB 271 HOD HASHARON, IS 972-9-7481-724 / 972-9-7481724	AR-8800	APNEA MONITOR - CLINICAL MODEL
3	BINZ MEDICAL CO., LTD. MEDICAL B.I. #106, 73-10, HEUNGUP WONJU, KANGWON-DO, 220-844 KS 82-33-766-2361 / 82-33-766-2361	CRM 1000, CRM 2000	TWO TYPES OF APNEA MONITORS
4	COVIDIEN LP, FORMERLY REGISTERED AS KENDALL 98.6 FAICHNEY DR. WATERTOWN, NY 13601 US 508-261-8587 / 508-261-8587	MONITOR (APNEA DETECTOR), VENTILATORY EFFORT	VARIOUS
5	DRAEGER MEDICAL SYSTEMS, INC. 16 ELECTRONICS AVE. DANVERS, MA 01923 US 215-660-2078 / 215-660-2078	PATIENT MONITORS, VARIOUS MODELS	MULTIPLE INFINITY SYSTEMS
6	EMBLA SYSTEMS, INC. 55 PINEVIEW DR., SUITE 100 BUFFALO, NY 14228 US 716-691-0718141 / 303-962-1786	REMBRANDT	SLEEP STUDY, DATA ACQUISITION SOFTWARE
7	EMBLA SYSTEMS, INC. 535 LEGGET DR., SUITE 500 OTTAWA, ONTARIO, K2K3B8 CA 716-691-0718141 / 303-962-1786	REMBRANDT	SLEEP STUDY, DATA ACQUISITION SOFTWARE
8	GRASS TECHNOLOGIES, AN ASTRO-MED, INC. PRODUCT GRO 53 AIRPORT PARK DRIVE ROCKLAND, MA 02370 US 401-828-4002 / 401-828-4000 244	GRASS MODEL DPRT DUAL PNEUMATIC RESPIRATION TRANSDUCER	RESPIRATORY EFFORT TRANSDUCER
9	MARCAL MEDICAL, INC. 1114 BENFIELD BLVD., SUITE H MILLERSVILLE, MD 21108 US 410-987-4001 / 410-987-4001	GRASEBY	VARIOUS NEONATAL MONITORS
10	NEXENSE, LTD. #1, HAKISHON YAVNE, 81220 IS 972-8-9328850 / 972-8-9328224	CHILD NEXAVER	APNEA MONITOR
11	PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. ANDOVER, MA 01810 US 425-487-7000 / 978-659-4252		RESPIRATION MONITOR
12	PRO-TECH SERVICES, INC. 4338 HARBOUR POINTE BLVD. S.W. MUKILTEO, WA 98275 US 425-322-0300 / 425-322-0300	MULTIPLE	VARIOUS
13	SLEEP SOLUTIONS, INC. 1525 ATTEBERRY LANE SAN JOSE, CA 95131 US 877-753-3775 / 866-682-9267	SILENT NIGHT	APNEA MONITOR
14	SMITHS MEDICAL INTERNATIONAL LTD. COLONIAL WAY WATFORD, HERTS., WD24 4LG UK 114-420-8-458-3232 / 44-192-3475809	MR10	RESPIRATION MONITOR