CARDIOLAB AMPLIFIER MODULE (CAM)

CARDIOLAB AMPLIFIER MODULE (CAM) is an FDA 510(k)-cleared medical device (K910307) manufactured by Prucka Engineering, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 11, 1991. Regulation: 8.