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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 K062080
Device Name RESUSCITATION TIMER, MODEL L770-CPR
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 Number868.5915
Classification Product Code
BTM  
Date Received07/21/2006
Decision Date 10/18/2006
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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