K231050
- 510(k) number
- K231050
- Device name
- Arm Blood Pressure Monitor
- Applicant
- Alicn Medical Shenzhen, Inc. CN
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2023-10-11
- Date received
- 2023-04-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K231050
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.