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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 K851220
Device Name SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664
Applicant
Northern Electric Co. Div. of Sunbeam Corp.
5224 N. Kedzie
Chicago,  IL  60625
Applicant Contact SCHECK
Correspondent
Northern Electric Co. Div. of Sunbeam Corp.
5224 N. Kedzie
Chicago,  IL  60625
Correspondent Contact SCHECK
Regulation Number868.5460
Classification Product Code
KFZ  
Date Received03/26/1985
Decision Date 09/17/1985
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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