KEOPS Balance Analyzer 3D— 510(k) K213975
Substantially EquivalentS.M.A.I.O
FDA 510(k) clearance K213975 for KEOPS Balance Analyzer 3D, Substantially Equivalent on 2022-05-06. Applicant: S.M.A.I.O. Device class: 2.
Clearance details
- Applicant
- S.M.A.I.O
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Saint-Priest, FR
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Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
Source: openFDA MAUDE database, through . 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.