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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, emergency, manual (resuscitator)
510(k) Number K014071
Device Name PMX DISPOSABLE BAG MASK RESUSCITATOR
Applicant
ALLIED HEALTHCARE PRODUCTS, INC.
1720 SUBLETTE AVE.
ST. LOUIS,  MO  63110
Applicant Contact VERNON TRIMBLE
Correspondent
ALLIED HEALTHCARE PRODUCTS, INC.
1720 SUBLETTE AVE.
ST. LOUIS,  MO  63110
Correspondent Contact VERNON TRIMBLE
Regulation Number868.5915
Classification Product Code
BTM  
Date Received12/10/2001
Decision Date 10/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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