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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Subsystem, Water Purification
510(k) Number K223656
Device Name AmeriWater MediQA Reverse Osmosis System (MSP3HF)
Applicant
AmeriWater, LLC
3345 Stop 8 Rd.
Dayton,  OH  45414
Applicant Contact Brian Bowman
Correspondent
AmeriWater, LLC
3345 Stop 8 Rd.
Dayton,  OH  45414
Correspondent Contact Brian Bowman
Regulation Number876.5665
Classification Product Code
FIP  
Date Received12/06/2022
Decision Date 02/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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