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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Non-Direct Patient Interface (Home-Use)
510(k) Number K830896
Device Name HUMIDIFIER, WITH OR WITHOUT ADAPTER
Applicant
AIRLIFE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AIRLIFE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5460
Classification Product Code
KFZ  
Date Received03/21/1983
Decision Date 04/18/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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