INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER

INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER is an FDA 510(k)-cleared medical device (K112601) manufactured by Intricon Datrix Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 8, 2011. Regulation: 8.