K261747
- 510(k) number
- K261747
- Device name
- Report Studio
- Applicant
- Beacon Biosignals, Inc. MA · US
- Product code
- OLV — Standard Polysomnograph With Electroencephalograph
- Decision date
- 2026-08-25
- Date received
- 2026-05-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K261747.pdf
Official FDA record: K261747
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.