K243243
- 510(k) number
- K243243
- Device name
- Delphi MCS Electrode Cap
- Applicant
- Quantalx Neuroscience, Ltd. IL
- Product code
- GXY — Electrode, Cutaneous
- Decision date
- 2025-02-06
- Date received
- 2024-10-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243243.pdf
Official FDA record: K243243
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.