K230826
- 510(k) number
- K230826
- Device name
- Modius Sleep
- Applicant
- Neurovalens , Ltd. GB
- Product code
- QJQ — Cranial Electrotherapy Stimulator To Treat Insomnia
- Decision date
- 2023-10-27
- Date received
- 2023-03-24
- 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: K230826.pdf
Official FDA record: K230826
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.