
Intricon Datrix Corporation
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INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS) is an FDA 510(k)-cleared medical device (K111160) 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 July 31, 2011. Regulation: 8.