AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR— 510(k) K102507

Substantially Equivalent

Tz Medical, Inc.

FDA 510(k) clearance K102507 for AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR, Substantially Equivalent on 2011-06-13. Applicant: Tz Medical, Inc..

Clearance details

Applicant: Tz Medical, Inc.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2010-09-01
Decision date: 2011-06-13
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

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.