3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM

Control, Pump Speed, 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 3m Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion System.

Pre-market Notification Details

Device IDK950739
510k NumberK950739
Device Name:3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM
ClassificationControl, Pump Speed, Cardiopulmonary Bypass
Applicant 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor,  MI  48106
ContactMartha Rumford
CorrespondentMartha Rumford
3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor,  MI  48106
Product CodeDWA  
CFR Regulation Number870.4380 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-17
Decision Date1995-11-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00886799000076 K950739 000

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