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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K190713
Device Name F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)
Applicant
Fisher & Paykel Healthcare Ltd.
15 Maurice Paykel Place, East Tamaki
auckland,  NZ 2013
Applicant Contact masar mohammad
Correspondent
Fisher & Paykel Healthcare Ltd.
15 Maurice Paykel Place, East Tamaki
auckland,  NZ 2013
Correspondent Contact masar mohammad
Regulation Number868.5905
Classification Product Code
BZD  
Date Received03/19/2019
Decision Date 10/11/2019
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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