COGNISION EEG/EP SYSTEM— 510(k) K141316
Substantially EquivalentNeuronetrix Solutions
FDA 510(k) clearance K141316 for COGNISION EEG/EP SYSTEM, Substantially Equivalent on 2015-02-13. Applicant: Neuronetrix Solutions.
Clearance details
- Applicant
- Neuronetrix Solutions
- Product code
- Code OLT
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Adverse events under product code OLT
product code OLT- Other
- 1
- Total
- 1
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.