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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K120027
Model 400420A
Device Name PILAIRO NASAL PILLOWS MASK
Original Applicant
FISHER & PAYKEL HEALTHCARE LIMITED
15 maurice paykel place
east tamaki
auckland,  NZ 2013
Original Contact tina mason
Regulation Number868.5905
Classification Product Code
BZD  
Date Received01/03/2012
Decision Date 02/23/2012
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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