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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, E. Tamaki
Auckland,  NZ 2013
Applicant Contact Masar Mohammad
Correspondent
Fisher &Paykel Healthcare , Ltd.
15 Maurice Paykel Place, E. 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
Predetermined Change
Control Plan Authorized		 No
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