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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name High Flow/High Velocity Humidified Oxygen Delivery Device
510(k) Number K221338
Device Name F&P Airvo 3
Applicant
Fisher & Paykel Health Care
15 Maurice Paykel Place
Manukau,  NZ 2013
Applicant Contact Reena Daken
Correspondent
Fisher & Paykel Health Care
15 Maurice Paykel Place
Manukau,  NZ 2013
Correspondent Contact Reena Daken
Regulation Number868.5454
Classification Product Code
QAV  
Date Received05/09/2022
Decision Date 01/27/2023
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
Recalls CDRH Recalls
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