HOLTER SSR DIGICORDER(TM)

HOLTER SSR DIGICORDER(TM) is an FDA 510(k)-cleared medical device (K942653) 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 May 9, 1995. Regulation: 8.