K231478
- 510(k) number
- K231478
- Device name
- Digital Blood Pressure Monitor (Model: YB-800)
- Applicant
- Wenzhou Yosun Medical Technology Co.,Ltd CN
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2023-12-15
- Date received
- 2023-05-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K231478.pdf
Official FDA record: K231478
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.