K232025
- 510(k) number
- K232025
- Device name
- Hushd Pro Avera
- Applicant
- Good Sleep CO Pte , Ltd. SG
- Product code
- LRK — Device, Anti-Snoring
- Decision date
- 2024-05-09
- Date received
- 2023-07-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K232025.pdf
Official FDA record: K232025
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.