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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K222292
Device Name F&P myAirvo 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 Number868.5450
Classification Product Code
BTT  
Date Received07/29/2022
Decision Date 05/08/2024
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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