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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
510(k) Number K873206
Device Name MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE
Applicant
Respiratory Support Products, Inc.
3183-D Airway Ave.
Costa Mesa,  CA  92626
Applicant Contact ANTHONY V BERAN
Correspondent
Respiratory Support Products, Inc.
3183-D Airway Ave.
Costa Mesa,  CA  92626
Correspondent Contact ANTHONY V BERAN
Regulation Number870.4340
Classification Product Code
DTW  
Date Received08/14/1987
Decision Date 09/30/1987
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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