K254304
- 510(k) number
- K254304
- Device name
- iNOS intraoral biosensor
- Applicant
- Achaemenid, LLC MA · US
- Product code
- PLC — Sleep Appliances With Patient Monitoring
- Decision date
- 2026-08-25
- Date received
- 2025-12-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K254304.pdf
Official FDA record: K254304
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.