DIGITAL ELECTROCARDIOGRAPH— 510(k) K131858

Substantially Equivalent

Guangdong Biolight Meditech Co., Ltd.

FDA 510(k) clearance K131858 for DIGITAL ELECTROCARDIOGRAPH, Substantially Equivalent on 2014-06-11. Applicant: Guangdong Biolight Meditech Co., Ltd..

Clearance details

Applicant: Guangdong Biolight Meditech Co., Ltd.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2013-06-24
Decision date: 2014-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

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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.