AmeriWater MediQA Reverse Osmosis System (MSP3HF)

AmeriWater MediQA Reverse Osmosis System (MSP3HF) is an FDA 510(k)-cleared medical device (K223656) manufactured by AmeriWater, LLC. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 12, 2023. Regulation: 8.