YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION— 510(k) K121025

Substantially Equivalent

Ya Horng Electronic Co., Ltd.

FDA 510(k) clearance K121025 for YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION, Substantially Equivalent on 2012-08-17. Applicant: Ya Horng Electronic Co., Ltd..

Clearance details

Applicant: Ya Horng Electronic Co., Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2012-04-04
Decision date: 2012-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin-Chu City, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.