K241066
- 510(k) number
- K241066
- Device name
- BB-613-BPM
- Applicant
- Biobeat Technologies , Ltd. IL
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2025-01-14
- Date received
- 2024-04-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K241066.pdf
Official FDA record: K241066
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.