Cerebral Autoregulation Index (CAI) Algorithm— 510(k) K240596
Substantially EquivalentEdwards Lifesciences
FDA 510(k) clearance K240596 for Cerebral Autoregulation Index (CAI) Algorithm, Substantially Equivalent on 2024-10-16. Applicant: Edwards Lifesciences. Device class: 2.
Clearance details
- Applicant
- Edwards Lifesciences
- Product code
- Code MUD
- Device class
- Class 2
- Regulation
- 21 CFR 870.2700
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code MUD
view allMore clearances from Edwards Lifesciences
view allAdverse events under product code MUD
product code MUD- Malfunction
- 467
- Total
- 467
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.