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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 K072214
Device Name PORTABLE VENTILATOR, MODEL EPV-100
Applicant
ALLIED HEALTHCARE PRODUCTS, INC.
1720 SUBLETTE AVE.
ST. LOUIS,  MO  63110
Applicant Contact WAYNE KARCHER
Correspondent
ALLIED HEALTHCARE PRODUCTS, INC.
1720 SUBLETTE AVE.
ST. LOUIS,  MO  63110
Correspondent Contact WAYNE KARCHER
Regulation Number868.5925
Classification Product Code
BTL  
Date Received08/09/2007
Decision Date 03/06/2008
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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