CDI (TM) SYSTEM 100 MONITORING SYSTEM

Sensor, Blood-gas, In-line, Cardiopulmonary Bypass

3M HEALTH CARE, LTD.

The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for Cdi (tm) System 100 Monitoring System.

Pre-market Notification Details

Device IDK902654
510k NumberK902654
Device Name:CDI (TM) SYSTEM 100 MONITORING SYSTEM
ClassificationSensor, Blood-gas, In-line, Cardiopulmonary Bypass
Applicant 3M HEALTH CARE, LTD. 2801 BARRANCA RD. Irvine,  CA  92714
ContactJohn L Gehrich
CorrespondentJohn L Gehrich
3M HEALTH CARE, LTD. 2801 BARRANCA RD. Irvine,  CA  92714
Product CodeDTY  
CFR Regulation Number870.4410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-06-15
Decision Date1990-11-05

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