MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM

MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM is an FDA 510(k)-cleared medical device (K013677) manufactured by Usfilter/Ionpure, 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 March 7, 2002. Regulation: 8.