OMNI-TRAK 3000 SERIES MANUFACTURED BY INVIVO CORPORATION

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Request for Information Form	Contact Information
Company Name	INVIVO CORPORATION
Address	12601 RESEARCH PKWY.
City, State, Zip	ORLANDO, FL 32826
Country	US
FDA Owner/Operator Phone	425-487-7000
FDA Medical Specialty Code	AN - Anesthesiology
FDA Product Code	CBR
FDA Classification Name	ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.)
FDA Device Classification Code	Standards
FDA Regulation Number	868.1700
FDA Common Generic Name	SIDE-STREAM MEAN N20 MONITOR
FDA Proprietary Device Name	OMNI-TRAK 3000 SERIES
FDA Owner / Operator Number	1217116
FDA Owner / Operator Name	PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
FDA Establishment Registration Number	1051786
FDA Registered Establishment Name	INVIVO CORPORATION
FDA Operation Code(s)	MM - Manufacturer MS - Specification Developer
FDA Listing Date	10-13-92
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	DRAEGER MEDICAL AG & CO. KG 53/55 MOISLINGER ALLEE LUEBECK, 23542 GM 49-451-8825367 / 49-451-8825367	VARIOUS	GAS MONITOR
2	GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 HELSINKI, FIN-00510 FI 847-277-5002 / 414-721-3945	MULTIPLE	VARIOUS PATIENT MONITORS/MODULES/ACCESSORIES
3	NIHON KOHDEN CORP. 31-4 NISHIOCHIAI, 1-CHOME, SHINJUKU-KU TOKYO, 161-8560 JA 81-3-5996-8000 / 81-3-5348-1721	MULTIGAS UNIT	MULTI-GAS ANALYZER
4	PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. ANDOVER, MA 01810 US 425-487-7000 / 978-659-4252	MULTIPLE	ANALYZER,GAS,NITROUS OXIDE,GASEOUS-PHASE(ANESTHETIC-CONCENTRATION)
5	PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 BOEBLINGEN, D 71034 GM 425-487-7000 / 978-659-4252	MULTIPLE	ANALYZER, GAS NITROUS OXIDE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION)
6	SPACELABS MEDICAL INC. 5150 220TH AVE SE ISSAQUAH, WA 98029 US 425-657-7200 / 425-657-7200 5970	MULTIGAS ANALYZERS AND ACCESSORIES	MULTIGAS ANALYZERS AND ACCESSORIES