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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K890817
Device Name OMNI-TRAK (PATIENT MONITOR)
Applicant
INVIVO RESEARCH, INC.
11800 RESEARCH PKWY.
SUITE A
ORLANDO,  FL  32826
Applicant Contact TOM W FOSHEE
Correspondent
INVIVO RESEARCH, INC.
11800 RESEARCH PKWY.
SUITE A
ORLANDO,  FL  32826
Correspondent Contact TOM W FOSHEE
Regulation Number868.1400
Classification Product Code
CCK  
Date Received02/17/1989
Decision Date 08/10/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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