SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL

Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass

3M COMPANY

The following data is part of a premarket notification filed by 3m Company with the FDA for Sarns 9000 Perfusion System W/alert Only Level.

Pre-market Notification Details

Device IDK900815
510k NumberK900815
Device Name:SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL
ClassificationMonitor And/or Control, Level Sensing, Cardiopulmonary Bypass
Applicant 3M COMPANY 6200 JACKSON RD. P.O. BOX 1247 Ann Arbor,  MI  48106
ContactJames Balun
CorrespondentJames Balun
3M COMPANY 6200 JACKSON RD. P.O. BOX 1247 Ann Arbor,  MI  48106
Product CodeDTW  
CFR Regulation Number870.4340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-21
Decision Date1990-05-09

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