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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 K240163
Device Name Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula
Applicant
Medline Industries, LP
Three Lakes Dr.
Northfiled,  IL  60093
Applicant Contact Sirisha Kommana
Correspondent
Medline Industries, LP
Three Lakes Dr.
Northfiled,  IL  60093
Correspondent Contact Sirisha Kommana
Regulation Number868.5450
Classification Product Code
BTT  
Date Received01/22/2024
Decision Date 09/27/2024
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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