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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 K110019
Device Name RESPIRATORY HUMIDIFER
Applicant
Fisher & Paykel Healthcare, Ltd.
15 Maurice Paykel Pl.
P.O. Box 14348, Panmure
Auckland,  NZ 1741
Applicant Contact ADELE BINDON
Correspondent
Fisher & Paykel Healthcare, Ltd.
15 Maurice Paykel Pl.
P.O. Box 14348, Panmure
Auckland,  NZ 1741
Correspondent Contact ADELE BINDON
Regulation Number868.5450
Classification Product Code
BTT  
Date Received01/03/2011
Decision Date 03/30/2012
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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