K250058
- 510(k) number
- K250058
- Device name
- NEAT 001
- Applicant
- Brain Electrophysiology Laboratory Company, LLC OR · US
- Product code
- OLZ — Automatic Event Detection Software For Polysomnograp
- Decision date
- 2025-04-10
- Date received
- 2025-01-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K250058.pdf
Official FDA record: K250058
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.