SARNS 7000 MONITOR MODULE

Console, Heart-lung Machine, 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 Sarns 7000 Monitor Module.

Pre-market Notification Details

Device IDK801097
510k NumberK801097
Device Name:SARNS 7000 MONITOR MODULE
ClassificationConsole, Heart-lung Machine, Cardiopulmonary Bypass
Applicant 3M HEALTH CARE, SARNS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDTQ  
CFR Regulation Number870.4220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-05-09
Decision Date1980-05-20

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