K233488
- 510(k) number
- K233488
- Device name
- Intra.Ox 2.0 Handheld Tissue Oximeter
- Applicant
- Vioptix, Inc. CA · US
- Product code
- MUD — Oximeter, Tissue Saturation
- Decision date
- 2024-02-28
- Date received
- 2023-10-27
- 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: K233488.pdf
Official FDA record: K233488
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.