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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Noninvasive Positive Airway Pressure System, Facility Use
510(k) Number K250651
Device Name OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun
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 Number868.5895
Classification Product Code
SGR  
Date Received03/04/2025
Decision Date 11/19/2025
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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