K242345
- 510(k) number
- K242345
- Device name
- Delphi Stimulator
- Applicant
- Quantalx Neuroscience IL
- Product code
- GWF — Stimulator, Electrical, Evoked Response
- Decision date
- 2024-11-05
- Date received
- 2024-08-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K242345.pdf
Official FDA record: K242345
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.