Reflow System Mini and ReFlow Mini Flusher

Reflow System Mini and ReFlow Mini Flusher is an FDA 510(k)-cleared medical device (K223603) manufactured by Anuncia Medical, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 28, 2022. Regulation: 8.