K233292
- 510(k) number
- K233292
- Device name
- ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
- Applicant
- Inomed Medizintechnik GmbH DE
- Product code
- GWF — Stimulator, Electrical, Evoked Response
- Decision date
- 2023-10-27
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233292.pdf
Official FDA record: K233292
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.