DIGITAL ELECTROCARDIOGRAPHS— 510(k) K131262

Substantially Equivalent

Sonoscape Company Limited

FDA 510(k) clearance K131262 for DIGITAL ELECTROCARDIOGRAPHS, Substantially Equivalent on 2013-11-14. Applicant: Sonoscape Company Limited.

Clearance details

Applicant: Sonoscape Company Limited
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2013-05-03
Decision date: 2013-11-14
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.