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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 K844420
Device Name MED-LIFE EMERGENCY OXYGEN REGREATHER/RESUSCITATOR
Applicant
Med-Life, Inc.
4520 Woodbend
Bryan,  TX  77803
Applicant Contact DONALD W WELCH
Correspondent
Med-Life, Inc.
4520 Woodbend
Bryan,  TX  77803
Correspondent Contact DONALD W WELCH
Regulation Number868.5915
Classification Product Code
BTM  
Date Received11/15/1984
Decision Date 12/17/1984
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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