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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 K901218
Device Name LIFE AID RESUSCITATOR
Applicant
Clarendon Supplies , Ltd.
Fountain Precinct, Balm Green
Sheffield S1 1rz
England,  GB
Applicant Contact L BROOMHEAD
Correspondent
Clarendon Supplies , Ltd.
Fountain Precinct, Balm Green
Sheffield S1 1rz
England,  GB
Correspondent Contact L BROOMHEAD
Regulation Number868.5915
Classification Product Code
BTM  
Date Received03/14/1990
Decision Date 05/18/1990
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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