K231068
- 510(k) number
- K231068
- Device name
- autoSCORE
- Applicant
- Holberg Eeg AS NO
- Product code
- OMB — Automatic Event Detection Software For Full-Montage
- Decision date
- 2024-01-07
- Date received
- 2023-04-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K231068.pdf
Official FDA record: K231068
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.