YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J; DIGITAL WRIST BLOOD PRESSURE MONITOR, BP-500,BP-500— 510(k) K072860

Substantially Equivalent

Ya Horng Electronic Co., Ltd.

FDA 510(k) clearance K072860 for YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J; DIGITAL WRIST BLOOD PRESSURE MONITOR, BP-500,BP-500, Substantially Equivalent on 2008-02-25. Applicant: Ya Horng Electronic Co., Ltd..

Clearance details

Applicant: Ya Horng Electronic Co., Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2007-10-05
Decision date: 2008-02-25
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.