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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 K121975
Models PT100US, PT101US
Device Name AIRVO HUMIDIFIER MYAIRO HUMIDIFIER
Original Applicant
FISHER & PAYKEL HEALTHCARE, LTD.
15 maurice paykel place
east tamaki
ackland,  NZ 2013
Original Contact brett whiston
Regulation Number868.5450
Classification Product Code
BTT  
Date Received07/05/2012
Decision Date 01/03/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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