BLOOD PRESSURE MONITOR, ZSBP-003/004/005/006/007/008 AND ZSBP-102/103/104/105/106/107— 510(k) K090027

Substantially Equivalent

Zen Strong Medical Technology Co., Ltd.

FDA 510(k) clearance K090027 for BLOOD PRESSURE MONITOR, ZSBP-003/004/005/006/007/008 AND ZSBP-102/103/104/105/106/107, Substantially Equivalent on 2009-02-02. Applicant: Zen Strong Medical Technology Co., Ltd..

Clearance details

Applicant: Zen Strong Medical Technology Co., Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2009-01-05
Decision date: 2009-02-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Keelung 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.