510(k) clearance
iNOS intraoral biosensor
- 510(k) number
- K254304
- Applicant
- Achaemenid, LLC
- Decision date
- Aug 25, 2026
- Date received
- Dec 31, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- PLC
- Device type
- Sleep Appliances With Patient Monitoring
- Device class
- Class II
- Regulation
- 21 CFR 872.5570
- Advisory committee
- Dental
- Statement or summary
- Summary
- Third party
- N
- Location
- Boston, MA, US