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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 K122432
Model RT380 AND RT385
Device Name ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS
Original Applicant
FISHER & PAYKEL HEALTHCARE, LTD.
15 maurice paykel place
east tamaki,  NZ 2013
Original Contact robert petry
Regulation Number868.5270
Classification Product Code
BZE  
Date Received08/10/2012
Decision Date 12/06/2012
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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