K260693
- 510(k) number
- K260693
- Device name
- VicorderCS (VCS-SYS-1100)
- Applicant
- 80 Beats Medical GmbH DE
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2026-06-16
- Date received
- 2026-03-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K260693.pdf
Official FDA record: K260693
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.