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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K851074
Device Name VARIABLE NEBULIZER HEATER
Applicant
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Applicant Contact BRIAN STEMBAL
Correspondent
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Correspondent Contact BRIAN STEMBAL
Regulation Number868.5630
Classification Product Code
CAF  
Date Received03/18/1985
Decision Date 06/18/1985
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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