K230195
- 510(k) number
- K230195
- Device name
- Neo ADVISE software
- Applicant
- Comerge AG CH
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2024-03-08
- Date received
- 2023-01-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K230195.pdf
Official FDA record: K230195
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.