RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT

RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT is an FDA 510(k)-cleared medical device (K072736) manufactured by Rhythmlink International, LLC. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 21, 2008. Regulation: 8.