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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 K882764
Device Name BEAR EVC-100 CONTROLLER
Applicant
BEAR MEDICAL SYSTEMS, INC.
2085 RUSTIN AVE.
RIVERSIDE,  CA  92507
Applicant Contact KAORU LEE
Correspondent
BEAR MEDICAL SYSTEMS, INC.
2085 RUSTIN AVE.
RIVERSIDE,  CA  92507
Correspondent Contact KAORU LEE
Regulation Number868.5895
Classification Product Code
CBK  
Date Received07/06/1988
Decision Date 09/30/1988
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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