K250136
- 510(k) number
- K250136
- Device name
- Globalcare Blood Pressure Monitor (GUS610)
- Applicant
- Globalcare Medical Technology Co., Ltd. CN
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2025-04-08
- Date received
- 2025-01-17
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.2 MB · U.S. public domain
Also available from FDA: K250136.pdf
Official FDA record: K250136
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.