SARNS ULTRASONIC AIR SENSOR

Detector, Bubble, 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 Ultrasonic Air Sensor.

Pre-market Notification Details

Device IDK940651
510k NumberK940651
Device Name:SARNS ULTRASONIC AIR SENSOR
ClassificationDetector, Bubble, Cardiopulmonary Bypass
Applicant 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor,  MI  48106
ContactTimothy J Kriewall, Ph.d.
CorrespondentTimothy J Kriewall, Ph.d.
3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor,  MI  48106
Product CodeKRL  
CFR Regulation Number870.4205 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-02-15
Decision Date1994-05-24

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