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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 K191818
Device Name F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)
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 Received07/05/2019
Decision Date 03/19/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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