K252161
- 510(k) number
- K252161
- Device name
- Hushd Avera
- Applicant
- Good Sleep CO Pte , Ltd. SG
- Product code
- LRK — Device, Anti-Snoring
- Decision date
- 2025-11-25
- Date received
- 2025-07-10
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252161.pdf
Official FDA record: K252161
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.