MONITOR KITS, BLOOD LEVEL

Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass

3M HEALTH CARE, SARNS

The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Monitor Kits, Blood Level.

Pre-market Notification Details

Device IDK781145
510k NumberK781145
Device Name:MONITOR KITS, BLOOD LEVEL
ClassificationMonitor And/or Control, Level Sensing, Cardiopulmonary Bypass
Applicant 3M HEALTH CARE, SARNS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDTW  
CFR Regulation Number870.4340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-07-10
Decision Date1978-07-27

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