FORE-SIGHT ELITE Absolute Tissue Oximeter— 510(k) K203490

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K203490 for FORE-SIGHT ELITE Absolute Tissue Oximeter, Substantially Equivalent on 2021-02-10. Applicant: Edwards Lifesciences, LLC.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code MUD
Advisory panel: Cardiovascular
Date received: 2020-11-27
Decision date: 2021-02-10
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.