510(k) K111160

INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS) by Intricon Datrix Corporation — Product Code DSI

K111160 is an FDA 510(k) premarket notification submitted by Intricon Datrix Corporation for the device "INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS)". The FDA issued a decision of Substantially Equivalent on August 1, 2011. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Intricon Datrix Corporation has at least 1 other 510(k) clearance on record.