K253982
- 510(k) number
- K253982
- Device name
- Korotkoff sound blood pressure monitor
- Applicant
- Beijing Hanvon Health Technology Co., Ltd. CN
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2026-04-21
- Date received
- 2025-12-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K253982.pdf
Official FDA record: K253982
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.