K253152
- 510(k) number
- K253152
- Device name
- BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)
- Applicant
- Biozen, LLC OK · US
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2026-05-06
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K253152.pdf
Official FDA record: K253152
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.