BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX— 510(k) K070473

Substantially Equivalent

Zen Strong Medical Technology Co., Ltd.

FDA 510(k) clearance K070473 for BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX, Substantially Equivalent on 2007-05-23. 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: 2007-02-20
Decision date: 2007-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Keelung,, 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.