HOLTA-MED INFORMER PLAYBACK

HOLTA-MED INFORMER PLAYBACK is an FDA 510(k)-cleared medical device (K832354) manufactured by Holta-Med. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 26, 1984. Regulation: 8.