Portable ECG Monitor (ECG3)— 510(k) K172862

Substantially Equivalent

Andon Health Co, Ltd.

FDA 510(k) clearance K172862 for Portable ECG Monitor (ECG3), Substantially Equivalent on 2018-07-24. Applicant: Andon Health Co, Ltd..

Clearance details

Applicant: Andon Health Co, Ltd.
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 2017-09-20
Decision date: 2018-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tianjin, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

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.