ECG Acquisition Systems— 510(k) K163607

Substantially Equivalent

Vales & Hills Biomedical Tech. , Ltd.

FDA 510(k) clearance K163607 for ECG Acquisition Systems, Substantially Equivalent on 2017-12-15. Applicant: Vales & Hills Biomedical Tech. , Ltd..

Clearance details

Applicant: Vales & Hills Biomedical Tech. , Ltd.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2016-12-21
Decision date: 2017-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, 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.