K242094
- 510(k) number
- K242094
- Device name
- Dreem 3S
- Applicant
- Beacon Biosignals, Inc. MA · US
- Product code
- OLZ — Automatic Event Detection Software For Polysomnograp
- Decision date
- 2024-11-22
- Date received
- 2024-07-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K242094.pdf
Official FDA record: K242094
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.