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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous, Minimal Ventilatory Support, Facility Use Ventilator
510(k) Number K170367
Device Name Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small
Applicant
Fisher and Paykel Healthcare Limited
15 Maurice Paykel Pl.
Auckland,  NZ 2013
Applicant Contact Danica Tung
Correspondent
Fisher and Paykel Healthcare Limited
15 Maurice Paykel Pl.
Auckland,  NZ 2013
Correspondent Contact Danica Tung
Regulation Number868.5895
Classification Product Code
MNT  
Date Received02/06/2017
Decision Date 08/24/2017
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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