REVERSE OSMOSIS SYSTEM

REVERSE OSMOSIS SYSTEM is an FDA 510(k)-cleared medical device (K944493) manufactured by G.E.M. Water Systems. 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 19, 1996. Regulation: 8.