FDA 510(k), K213507, AquaA

FDA 510(k), K213507, AquaA

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510(K) Number: K213507
Device Name: AquaA
Manufacturer: Fresenius Medical Care Rental Therapies Group, LLC
Device Classification Name: Subsystem, Water Purification
Regulation Number: 876.5665
Classification Product Code: FIP
Date Received: 11/01/2021
Decision Date: 07/27/2022
Regulation Medical Specialty: Gastroenterology/Urology

Total Pages: 5,340
Fully Redacted Pages: 4,586
Content Pages: 754
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