
B.Braun Medical, Inc.
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AQUAbase nX is an FDA 510(k)-cleared medical device (K223479) manufactured by B.Braun Medical, Inc.. 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 August 15, 2023. Regulation: 8.