K234080
- 510(k) number
- K234080
- Device name
- MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)
- Applicant
- Soterix Medical, Inc. NJ · US
- Product code
- GWF — Stimulator, Electrical, Evoked Response
- Decision date
- 2024-03-25
- Date received
- 2023-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.5 MB · U.S. public domain
Also available from FDA: K234080.pdf
Official FDA record: K234080
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.