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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 K083385
Device Name MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B
Applicant
Allied Healthcare Products, Inc.
1720 Sublette Ave.
Saint Louis,  MO  63110
Applicant Contact WAYNE KARCHER
Correspondent
Allied Healthcare Products, Inc.
1720 Sublette Ave.
Saint Louis,  MO  63110
Correspondent Contact WAYNE KARCHER
Regulation Number868.5925
Classification Product Code
BTL  
Date Received11/17/2008
Decision Date 05/14/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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