K252448
- 510(k) number
- K252448
- Device name
- AViTA Pulse Oximeter (SP61)
- Applicant
- Avita Corporation CN
- Product code
- DQA — Oximeter
- Decision date
- 2026-02-27
- Date received
- 2025-08-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K252448.pdf
Official FDA record: K252448
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.