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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, Minimal Ventilatory Support, Facility Use
510(k) Number K191624
Device Name F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version
Applicant
Fisher & Paykel Healthcare Limited
15 Maurice Paykel Place
Auckland,  NZ 2013
Applicant Contact Nicholas Yap
Correspondent
Fisher & Paykel Healthcare Limited
15 Maurice Paykel Place
Auckland,  NZ 2013
Correspondent Contact Reena Daken
Regulation Number868.5895
Classification Product Code
MNT  
Date Received06/18/2019
Decision Date 03/09/2020
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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