K261061
- 510(k) number
- K261061
- Device name
- BP Go (BPP-855)
- Applicant
- Wellvii, Inc. FL · US
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2026-08-13
- Date received
- 2026-03-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K261061.pdf
Official FDA record: K261061
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.