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510(k) K034026

RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS by Fisher &Paykel Healthcare , Ltd. — Product Code BZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2005
Date Received
December 29, 2003
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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