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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 K923660
Device Name MEDISONIC OXYGEN FLOW CONTROLLER
Applicant
Medisonic U.S.A., Inc.
9600 Main St.
Clarence,  NY  14031
Applicant Contact DON TRAINER
Correspondent
Medisonic U.S.A., Inc.
9600 Main St.
Clarence,  NY  14031
Correspondent Contact DON TRAINER
Regulation Number868.5905
Classification Product Code
NFB  
Date Received07/22/1992
Decision Date 01/27/1993
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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