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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 K953392
Device Name HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES)
Applicant
Fisher & Paykel Electronics , Ltd.
25 Carbine Rd. Panmure
P.O. Box 14 348 Panmure
Auckland, New Zealand,  NZ
Applicant Contact CHRIS MANDER
Correspondent
Fisher & Paykel Electronics , Ltd.
25 Carbine Rd. Panmure
P.O. Box 14 348 Panmure
Auckland, New Zealand,  NZ
Correspondent Contact CHRIS MANDER
Regulation Number868.5450
Classification Product Code
BTT  
Date Received07/19/1995
Decision Date 03/12/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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