K233403
- 510(k) number
- K233403
- Device name
- Flexset System
- Applicant
- Zeto, Inc. NC · US
- Product code
- GWQ — Full-Montage Standard Electroencephalograph
- Decision date
- 2024-04-30
- Date received
- 2023-10-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K233403.pdf
Official FDA record: K233403
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.