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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 K231956
Device Name F&P Optiflow+ Duet Nasal Cannula
Applicant
Fisher &Paykel Healthcare , Ltd.
15 Maurice Paykel Place, E. Tamaki
Auckland,  NZ 2013
Applicant Contact Reena Daken
Correspondent
Fisher &Paykel Healthcare , Ltd.
15 Maurice Paykel Place, E. Tamaki
Auckland,  NZ 2013
Correspondent Contact Reena Daken
Regulation Number868.5450
Classification Product Code
BTT  
Date Received07/03/2023
Decision Date 02/07/2024
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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