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510(k) K103767

DUAL HEATED INFANT VREATHING CIROUITS by Fisher &Paykel Healthcare , Ltd. — Product Code BZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2012
Date Received
December 23, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Device Class
Class II
Regulation Number
868.5270
Review Panel
AN
Submission Type

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