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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K230602
Device Name Hudson RCI® TurboMist™ Nebulizer System
Applicant
Medline Industries LP
Three Lakes Drive
Northfield,  IL  60093
Applicant Contact Lakshmi Kanuri
Correspondent
Medline Industries LP
Three Lakes Drive
Northfield,  IL  60093
Correspondent Contact Lakshmi Kanuri
Regulation Number868.5630
Classification Product Code
CAF  
Date Received03/03/2023
Decision Date 10/31/2023
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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