BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE

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 1000, Veolar W Leonardo Graphics, Bicore Cp-2000, Bicore Cp-100, Hi-lo Jet Et Tube.

Pre-market Notification Details

Device IDK983981
510k NumberK983981
Device Name:BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE
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 Received1998-11-09
Decision Date1998-11-20
Summary:summary

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