K250765
- 510(k) number
- K250765
- Device name
- AViTA Arm Type Blood Pressure Monitor Cuff
- Applicant
- Avita Corporation TW
- Product code
- DXQ — Blood Pressure Cuff
- Decision date
- 2025-09-03
- Date received
- 2025-03-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250765.pdf
Official FDA record: K250765
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.