K243324
- 510(k) number
- K243324
- Device name
- Masimo O3 Regional Oximeter
- Applicant
- Masimo Corporation CA · US
- Product code
- MUD — Oximeter, Tissue Saturation
- Decision date
- 2025-07-17
- Date received
- 2024-10-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K243324.pdf
Official FDA record: K243324
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.