BEAR CUB 750 PSV

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 Cub 750 Psv.

Pre-market Notification Details

Device IDK992788
510k NumberK992788
Device Name:BEAR CUB 750 PSV
ClassificationVentilator, Continuous, Facility Use
Applicant BEAR MEDICAL SYSTEMS, INC. 1100 BIRD CENTER DR. Palm Springs,  CA  92262
ContactDarryl Shelby
CorrespondentDarryl Shelby
BEAR MEDICAL SYSTEMS, INC. 1100 BIRD CENTER DR. Palm Springs,  CA  92262
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-19
Decision Date1999-09-16
Summary:summary

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