DIGITAL ELECTROCARDIOGRAPH— 510(k) K112431

Name: FDA 510(k) clearance K112431
Creator: U.S. Food and Drug Administration
Published: 2011-09-22

Substantially Equivalent

Shenzhen Biocare Electronics Co., Ltd.

FDA 510(k) clearance K112431 for DIGITAL ELECTROCARDIOGRAPH, Substantially Equivalent on 2011-09-22. Applicant: Shenzhen Biocare Electronics Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Biocare Electronics Co., Ltd.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 2011-08-23
Decision date: 2011-09-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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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.