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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K781600
Device Name MISTY-OX PREFILLED HUMIDIFIER, DISP.
Applicant
Davco
15902 Manufacture Ln.
Huntington Beach,  CA  92649
Applicant Contact Richard E Hart
Correspondent
Davco
15902 Manufacture Ln.
Huntington Beach,  CA  92649
Correspondent Contact Richard E Hart
Regulation Number868.5450
Classification Product Code
BTT  
Date Received09/18/1978
Decision Date 10/31/1978
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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