K200655

Substantially Equivalent

FibroScan® 630

Applicant: Echosens
Product code: IYO
Advisory panel: Radiology
Date received: 2020-03-12
Decision date: 2020-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

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.