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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 K121597
Device Name ESON NASAL MASK
Original Applicant
FISHER & PAYKEL HEALTHCARE LIMITED
15 maurice paykel place
east tamaki
auckland,  NZ 2013
Original Contact james thompson
Regulation Number868.5905
Classification Product Code
BZD  
Date Received05/31/2012
Decision Date 10/02/2012
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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