K242193
- 510(k) number
- K242193
- Device name
- Arm Type Blood Pressure Monitor (BPM82)
- Applicant
- Avita Corporation TW
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2024-10-22
- Date received
- 2024-07-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K242193.pdf
Official FDA record: K242193
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.