U80 Series Upper Arm Electronic Blood Pressure Monitor— 510(k) K160019

Substantially Equivalent

Shenzhen Urion Technology Co., Ltd.

FDA 510(k) clearance K160019 for U80 Series Upper Arm Electronic Blood Pressure Monitor, Substantially Equivalent on 2016-04-22. Applicant: Shenzhen Urion Technology Co., Ltd..

Clearance details

Applicant: Shenzhen Urion Technology Co., Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2016-01-05
Decision date: 2016-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

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.