Cerebral Autoregulation Index (CAI) Algorithm— 510(k) K240596

Substantially Equivalent

Edwards Lifesciences

FDA 510(k) clearance K240596 for Cerebral Autoregulation Index (CAI) Algorithm, Substantially Equivalent on 2024-10-16. Applicant: Edwards Lifesciences.

Clearance details

Applicant: Edwards Lifesciences
Product code: Code MUD
Advisory panel: Cardiovascular
Date received: 2024-03-04
Decision date: 2024-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MUD

product code MUD

Malfunction: 467
Total: 467

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.