MiCor A100 Wearable ECG Recorder— 510(k) K162665

Substantially Equivalent

Mitac International Corp.

FDA 510(k) clearance K162665 for MiCor A100 Wearable ECG Recorder, Substantially Equivalent on 2018-01-26. Applicant: Mitac International Corp..

Clearance details

Applicant: Mitac International Corp.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2016-09-26
Decision date: 2018-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taoyuan City, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.