EOlife®— 510(k) K221841

Substantially Equivalent

Archeon

FDA 510(k) clearance K221841 for EOlife®, Substantially Equivalent on 2023-03-18. Applicant: Archeon.

Clearance details

Applicant: Archeon
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 2022-06-24
Decision date: 2023-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Besançon, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTM

product code BTM

Death: 19
Other: 2
Total: 21

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.