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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 K034026
Device Name RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS
Applicant
Fisher & Paykel Healthcare, Ltd.
15 Maurice Paykel Pl.
Auckland,  NZ 1701
Applicant Contact ADELE BINDON
Correspondent
Fisher & Paykel Healthcare, Ltd.
15 Maurice Paykel Pl.
Auckland,  NZ 1701
Correspondent Contact ADELE BINDON
Regulation Number868.5270
Classification Product Code
BZE  
Date Received12/29/2003
Decision Date 01/12/2005
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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