FDA 510(k) K223656, AmeriWater MediQA Reverse Osmosis System (MSP3HF), by AmeriWater, LLC
FDA 510(k) K223656, AmeriWater MediQA Reverse Osmosis System (MSP3HF), by AmeriWater, LLC
Device Classification Name: Subsystem, Water Purification
510(k) Number: K223656
Device Name: AmeriWater MediQA Reverse Osmosis System (MSP3HF)
Applicant: AmeriWater, LLC
Regulation Number: 876.5665
Classification Product Code: FIP
Date Received: 2022-12-06
Decision Date: 2023-02-13
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
510k Review Panel: Gastroenterology/Urology
Total number of pages: 611
Fully redacted pages: 361
Content pages: 250
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