K250136

Substantially Equivalent

Globalcare Blood Pressure Monitor (GUS610)

Applicant: Globalcare Medical Technology Co., Ltd.
Product code: DXN
Advisory panel: Cardiovascular
Date received: 2025-01-17
Decision date: 2025-04-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Guangdong, 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.