K240596
- 510(k) number
- K240596
- Device name
- Cerebral Autoregulation Index (CAI) Algorithm
- Applicant
- Edwards Lifesciences CA · US
- Product code
- MUD — Oximeter, Tissue Saturation
- Decision date
- 2024-10-16
- Date received
- 2024-03-04
- 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: K240596.pdf
Official FDA record: K240596
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.