FDA 510(k) Applications for Medical Device Product Code "DTY"
(Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass)

FDA 510(k) Number Applicant Device Name Decision Date
K902654 3M HEALTH CARE, LTD. CDI (TM) SYSTEM 100 MONITORING SYSTEM 11/05/1990
K900860 CARDIO METRICS, INC. PERFUSION MONITOR 08/14/1990
K822000 CARDIOVASCULAR DEVICES, INC. EXTRACORPOREAL BLOOD GAS SYSTEM 12/22/1982
K840749 CARDIOVASCULAR DEVICES, INC. GAST STAT MONITORING SYSTEM 04/17/1984
K864703 CARDIOVASCULAR DEVICES, INC. MODIFIED GAS-STAT(TM) MONITORING SYSTEM 02/19/1987
K963698 INTERNATIONAL BIOPHYSICS CORP. CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 03/20/1997
K954501 MEDTRONIC BIO-MEDICUS, INC. BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM 01/16/1996
K093650 MEDTRONIC INC. BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM 02/17/2010


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