510(k) K223479

AQUAbase nX by B.Braun Medical, Inc. — Product Code FIP

K223479 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "AQUAbase nX". The FDA issued a decision of Substantially Equivalent on August 16, 2023. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. B.Braun Medical, Inc. has at least 10 other 510(k) clearances on record.