K252769

Substantially Equivalent

Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116)

Applicant: Shenzhen Finicare Co., Ltd.
Product code: DXN
Advisory panel: Cardiovascular
Date received: 2025-09-02
Decision date: 2025-10-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Shenzhen, CN

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.