K233438
- 510(k) number
- K233438
- Device name
- SleepStageML
- Applicant
- Beacon Biosignals, Inc. MA · US
- Product code
- OLZ — Automatic Event Detection Software For Polysomnograp
- Decision date
- 2024-03-08
- Date received
- 2023-10-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K233438.pdf
Official FDA record: K233438
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.