K242352
- 510(k) number
- K242352
- Device name
- Accurate Mini Non-invasive blood pressure monitor (AMB-001)
- Applicant
- Accurate Meditech, Inc. TW
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2025-02-05
- Date received
- 2024-08-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K242352.pdf
Official FDA record: K242352
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.