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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 PLACE
AUCKLAND,  NZ 1701
Applicant Contact ADELE BINDON
Correspondent
FISHER & PAYKEL HEALTHCARE, LTD.
15 MAURICE PAYKEL PLACE
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
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