K243982
- 510(k) number
- K243982
- Device name
- Nicolet EDX
- Applicant
- Natus Neurology Incorporated WI · US
- Product code
- GWF — Stimulator, Electrical, Evoked Response
- Decision date
- 2025-01-22
- Date received
- 2024-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243982.pdf
Official FDA record: K243982
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.