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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 K253479
Device Name Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
Applicant
Fisher &Paykel Healthcare , Ltd.
15 Maurice Paykel Place, E. Tamaki
Auckland,  NZ 2013
Applicant Contact Jung Yun Lee
Correspondent
Fisher &Paykel Healthcare , Ltd.
15 Maurice Paykel Place, E. Tamaki
Auckland,  NZ 2013
Correspondent Contact Jung Yun Lee
Regulation Number868.5450
Classification Product Code
BTT  
Date Received10/14/2025
Decision Date 12/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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