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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name humidifier, respiratory gas, (direct patient interface)
510(k) Number K110019
Device Name RESPIRATORY HUMIDIFER
Applicant
FISHER & PAYKEL HEALTHCARE, LTD.
15 MAURICE PAYKEL PLACE
P.O. BOX 14348, PANMURE
AUCKLAND,  NZ 1741
Applicant Contact ADELE BINDON
Correspondent
FISHER & PAYKEL HEALTHCARE, LTD.
15 MAURICE PAYKEL PLACE
P.O. BOX 14348, PANMURE
AUCKLAND,  NZ 1741
Correspondent Contact ADELE BINDON
Regulation Number868.5450
Classification Product Code
BTT  
Date Received01/03/2011
Decision Date 03/30/2012
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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