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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
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