K243746
- 510(k) number
- K243746
- Device name
- Delphi Amplifier
- Applicant
- Quantalx Neroscience IL
- Product code
- GWL — Amplifier, Physiological Signal
- Decision date
- 2025-03-12
- Date received
- 2024-12-05
- 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: K243746.pdf
Official FDA record: K243746
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.