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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 K932570
Device Name MARK I HUMIDIFIER
Applicant
C.F. Electronics, Inc.
5 Brayton Ct.
Commack,  NY  11725
Applicant Contact ROBERT FREEDMAN
Correspondent
C.F. Electronics, Inc.
5 Brayton Ct.
Commack,  NY  11725
Correspondent Contact ROBERT FREEDMAN
Regulation Number868.5450
Classification Product Code
BTT  
Date Received05/27/1993
Decision Date 08/25/1993
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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