K242455
- 510(k) number
- K242455
- Device name
- AViTA Pulse Oximeter (SP62B)
- Applicant
- Avita Corporation TW
- Product code
- DQA — Oximeter
- Decision date
- 2025-02-19
- Date received
- 2024-08-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K242455.pdf
Official FDA record: K242455
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.