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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 K924354
Device Name STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR
Applicant
Sorin Biomedica, Fiat, USA, Inc.
17600 Gilette Ave.
Irvine,  CA  92713
Applicant Contact DAVID TAYLOR
Correspondent
Sorin Biomedica, Fiat, USA, Inc.
17600 Gilette Ave.
Irvine,  CA  92713
Correspondent Contact DAVID TAYLOR
Regulation Number870.4340
Classification Product Code
DTW  
Date Received08/12/1992
Decision Date 02/18/1993
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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