K250122
- 510(k) number
- K250122
- Device name
- SleepRight Snore Aid
- Applicant
- Splintek, Inc. KS · US
- Product code
- LRK — Device, Anti-Snoring
- Decision date
- 2025-05-19
- Date received
- 2025-01-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250122.pdf
Official FDA record: K250122
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.