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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, powered (resuscitator)
510(k) Number K131098
Device Name EMERGENCY PORTABLE VENTILATOR
Applicant
ALLIED HEALTHCARE PRODUCTS, INC.
1720 SUBLETTE AVE.
ST LOUIS,  MO  63110
Applicant Contact STEPHEN MUNDWILLER
Correspondent
ALLIED HEALTHCARE PRODUCTS, INC.
1720 SUBLETTE AVE.
ST LOUIS,  MO  63110
Correspondent Contact STEPHEN MUNDWILLER
Regulation Number868.5925
Classification Product Code
BTL  
Date Received04/18/2013
Decision Date 04/09/2014
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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