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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K173060
Device Name F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version
Applicant
Fisher and Paykel Healthcare Limited
15 Maurice Paykel Pl.
Auckland,  NZ 2013
Applicant Contact Ashley Nguyen
Correspondent
Fisher and Paykel Healthcare Limited
15 Maurice Paykel Pl.
Auckland,  NZ 2013
Correspondent Contact Ashley Nguyen
Regulation Number868.5895
Classification Product Code
CBK  
Date Received09/28/2017
Decision Date 01/25/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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