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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 K955865
Device Name BEAR CUB INFANT PRESSURE VENTILATOR
Applicant
ALLIED HEALTHCARE PRODUCTS, INC.
2085 RUSTIN AVE.
RIVERSIDE,  CA  92507
Applicant Contact STANLEY E FRY
Correspondent
ALLIED HEALTHCARE PRODUCTS, INC.
2085 RUSTIN AVE.
RIVERSIDE,  CA  92507
Correspondent Contact STANLEY E FRY
Regulation Number868.5895
Classification Product Code
CBK  
Date Received12/28/1995
Decision Date 08/06/1996
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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