K250415
- 510(k) number
- K250415
- Device name
- G0 Blood Pressure Monitoring System (G0)
- Applicant
- Aktiia SA CH
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2025-07-02
- Date received
- 2025-02-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K250415.pdf
Official FDA record: K250415
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.