510(k) K213975— KEOPS Balance Analyzer 3D

Substantially Equivalent

S.M.A.I.O

Clearance details

Applicant: S.M.A.I.O
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2021-12-20
Decision date: 2022-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint-Priest, FR

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.