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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conserver, Oxygen
510(k) Number K883216
Device Name BUNN MODEL 50 OXYGEN FLOW CONTROLLER
Applicant
THE JOHN BUNN CO.
290 CREEKSIDE DR.
TONAWANDA,  NY  14150
Applicant Contact DENNIS KENYON
Correspondent
THE JOHN BUNN CO.
290 CREEKSIDE DR.
TONAWANDA,  NY  14150
Correspondent Contact DENNIS KENYON
Regulation Number868.5905
Classification Product Code
NFB  
Date Received07/29/1988
Decision Date 08/18/1988
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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