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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 ROAD PANMURE
P.O. BOX 14 348 PANMURE
AUCKLAND, NEW ZEALAND,  NZ
Applicant Contact CHRIS MANDER
Correspondent
FISHER & PAYKEL ELECTRONICS LTD.
25 CARBINE ROAD 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
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