HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)

HOLTER DIGICORDER WITH PACER OPTION (MODEL 483) is an FDA 510(k)-cleared medical device (K963174) manufactured by Del Mar Avionics. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 12, 1997. Regulation: 8.