K111160

Substantially Equivalent

INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS)

Applicant: Intricon Datrix Corporation
Product code: DSI
Advisory panel: Cardiovascular
Date received: 2011-04-25
Decision date: 2011-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Appollo Beach, FL, US

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.