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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 PLACE
PO BOX 14648
AUCKLAND,  NZ 1071
Applicant Contact ROBERT PETRY
Correspondent
FISHER & PAYKEL HEALTHCARE LTD.
15 MAURICE PAYKEL PLACE
PO 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
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