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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 K251448
Device Name FL-10000U Respiratory Humidifier
Applicant
Flexicare Medical Limited.
Cynon Valley Business Park Mountain Ash. Cf45 4er.
Rhondda Cynon Taf,  GB CF45 4ER
Applicant Contact Rebecca Funston
Correspondent
Flexicare Medical Limited.
Cynon Valley Business Park Mountain Ash. Cf45 4er.
Rhondda Cynon Taf,  GB CF45 4ER
Correspondent Contact Rebecca Funston
Regulation Number868.5450
Classification Product Code
BTT  
Subsequent Product Code
BZE  
Date Received05/09/2025
Decision Date 01/16/2026
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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