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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 K233821
Device Name F&P Optiflow Oxygen Kit (AA451J)
Applicant
Fisher & Paykel Healthcare Ltd
15 Maurice Paykel Place, East Tamaki
Auckland,  NZ 2013
Applicant Contact Reena Daken
Correspondent
Fisher & Paykel Healthcare Ltd
15 Maurice Paykel Place, East Tamaki
Auckland,  NZ 2013
Correspondent Contact Reena Daken
Regulation Number868.5450
Classification Product Code
BTT  
Date Received12/01/2023
Decision Date 06/13/2024
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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