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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, Oxygen, Partial Pressure, Blood-Phase, Indwelling
510(k) Number K843912
Device Name INTRAVASCULAR BLOOD GAS SYSTEM
Applicant
Cardiovascular Devices, Inc.
2801 Barranca
Irvine,  CA  92714
Applicant Contact JOHN L GEHRICH
Correspondent
Cardiovascular Devices, Inc.
2801 Barranca
Irvine,  CA  92714
Correspondent Contact JOHN L GEHRICH
Regulation Number868.1200
Classification Product Code
CCE  
Date Received10/03/1984
Decision Date 01/10/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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