DIGITAL ELECTROCARDIOGRAPHS— 510(k) K123816

Substantially Equivalent

Shenzhen Biocare Electronics Co., Ltd.

FDA 510(k) clearance K123816 for DIGITAL ELECTROCARDIOGRAPHS, Substantially Equivalent on 2013-02-27. Applicant: Shenzhen Biocare Electronics Co., Ltd..

Clearance details

Applicant: Shenzhen Biocare Electronics Co., Ltd.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2012-12-12
Decision date: 2013-02-27
Decision: Substantially Equivalent
Clearance type: Special
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.