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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 K070636
Device Name AUTOVENT 4000 WITH CPAP
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 Received03/07/2007
Decision Date 07/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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