K223399
- 510(k) number
- K223399
- Device name
- AViTA Pulse Oximeter
- Applicant
- Avita Corporation TW
- Product code
- DQA — Oximeter
- Decision date
- 2024-05-20
- Date received
- 2022-11-09
- 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: K223399.pdf
Official FDA record: K223399
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.