AI-ECG Tracker— 510(k) K200036

Substantially Equivalent

Shenzhen Carewell Electronics Co., Ltd.

FDA 510(k) clearance K200036 for AI-ECG Tracker, Substantially Equivalent on 2020-03-20. Applicant: Shenzhen Carewell Electronics Co., Ltd..

Clearance details

Applicant: Shenzhen Carewell Electronics Co., Ltd.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2020-01-08
Decision date: 2020-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

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.