K253059
- 510(k) number
- K253059
- Device name
- Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)
- Applicant
- Tournicare Pty, Ltd. AU
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2026-06-15
- Date received
- 2025-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K253059.pdf
Official FDA record: K253059
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.