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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K881335
Device Name BEAR 3 VENTILATOR
Applicant
BEAR MEDICAL SYSTEMS, INC.
2085 RUSTIN AVE.
RIVERSIDE,  CA  92507
Applicant Contact MIKE COLLINS
Correspondent
BEAR MEDICAL SYSTEMS, INC.
2085 RUSTIN AVE.
RIVERSIDE,  CA  92507
Correspondent Contact MIKE COLLINS
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/29/1988
Decision Date 08/04/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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