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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
510(k) Number K103767
Device Name DUAL HEATED INFANT VREATHING CIROUITS
Applicant
Fisher & Paykel Healthcare, Ltd.
15 Maurice Paykel Pl.
P.O. Box 14648
Auckland,  NZ 1071
Applicant Contact ROBERT PETRY
Correspondent
Fisher & Paykel Healthcare, Ltd.
15 Maurice Paykel Pl.
P.O. Box 14648
Auckland,  NZ 1071
Correspondent Contact ROBERT PETRY
Regulation Number868.5270
Classification Product Code
BZE  
Date Received12/23/2010
Decision Date 04/16/2012
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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