MDPHONE CELLULAR + RESCUE (DEFIB SYSTEM)

MDPHONE CELLULAR + RESCUE (DEFIB SYSTEM) is an FDA 510(k)-cleared medical device (K911604) manufactured by Medphone Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 22, 1991. Regulation: 8.