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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 K223100
Device Name Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)
Applicant
Medline Industries, Inc.
1 Three Lake Dr.
Northfiled,  IL  60093
Applicant Contact Nichole Schaffer
Correspondent
RQM+
2790 Mosside Blvd., Suite 800
Monroeville,,  PA  15146
Correspondent Contact Joy Gutermuth
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/30/2022
Decision Date 06/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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