K240646
- 510(k) number
- K240646
- Device name
- DreamClear
- Applicant
- Somnomed Technologies Inc., Doing Business AS Remware FL · US
- Product code
- GWL — Amplifier, Physiological Signal
- Decision date
- 2024-09-04
- Date received
- 2024-03-07
- 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: K240646.pdf
Official FDA record: K240646
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.