BEAR 7 VENTILATOR

Ventilator, Continuous, Facility Use

BEAR MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Bear Medical Systems, Inc. with the FDA for Bear 7 Ventilator.

Pre-market Notification Details

Device IDK912619
510k NumberK912619
Device Name:BEAR 7 VENTILATOR
ClassificationVentilator, Continuous, Facility Use
Applicant BEAR MEDICAL SYSTEMS, INC. 2085 RUSTIN AVE. Riverside,  CA  92507
ContactLee Adair
CorrespondentLee Adair
BEAR MEDICAL SYSTEMS, INC. 2085 RUSTIN AVE. Riverside,  CA  92507
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-06-13
Decision Date1992-06-11

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