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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
510(k) Number K864703
Device Name MODIFIED GAS-STAT(TM) MONITORING SYSTEM
Applicant
Cardiovascular Devices, Inc.
2801 Barranca
Irvine,  CA  92714
Applicant Contact GEHRICH, PHD
Correspondent
Cardiovascular Devices, Inc.
2801 Barranca
Irvine,  CA  92714
Correspondent Contact GEHRICH, PHD
Regulation Number870.4410
Classification Product Code
DTY  
Date Received12/02/1986
Decision Date 02/19/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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