ELECTROCARDIOGRAPH— 510(k) K113485

Substantially Equivalent

Shenzhen Carewell Electronics Co., Ltd.

FDA 510(k) clearance K113485 for ELECTROCARDIOGRAPH, Substantially Equivalent on 2012-04-25. Applicant: Shenzhen Carewell Electronics Co., Ltd..

Clearance details

Applicant: Shenzhen Carewell Electronics Co., Ltd.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2011-11-23
Decision date: 2012-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, 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.