FibroScan 230— 510(k) K212035

Substantially Equivalent

Echosens

FDA 510(k) clearance K212035 for FibroScan 230, Substantially Equivalent on 2021-07-30. Applicant: Echosens.

Clearance details

Applicant: Echosens
Product code: Code IYO
Advisory panel: Radiology
Date received: 2021-06-30
Decision date: 2021-07-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Paris, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.