INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS)— 510(k) K111160

Name: FDA 510(k) clearance K111160
Creator: U.S. Food and Drug Administration
Published: 2011-08-01

Substantially Equivalent

Intricon Datrix Corporation

FDA 510(k) clearance K111160 for INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS), Substantially Equivalent on 2011-08-01. Applicant: Intricon Datrix Corporation. Device class: 2.

Clearance details

Applicant: Intricon Datrix Corporation
Product code: Code DSI
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 2011-04-25
Decision date: 2011-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Appollo Beach, FL, US

Download summary PDF View on FDA.gov ↗

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K112601 — INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER2011-11-09

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.