QOCA Portable ECG Monitoring Device— 510(k) K210179

Substantially Equivalent

Quanta Computer, Inc.

FDA 510(k) clearance K210179 for QOCA Portable ECG Monitoring Device, Substantially Equivalent on 2022-08-02. Applicant: Quanta Computer, Inc..

Clearance details

Applicant: Quanta Computer, Inc.
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 2021-01-22
Decision date: 2022-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taoyuan City, TW

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.