510(k) K230532
K230532 is an FDA 510(k) premarket notification submitted by Achaemenid, LLC for the device "RADx Intraoral Appliance for Snoring and Sleep Apnea". The FDA issued a decision of Substantially Equivalent on July 12, 2023. The device falls under product code LQZ (Device, Jaw Repositioning), a Class II device regulated under 21 CFR 872.5570. Achaemenid, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 2023
- Date Received
- February 27, 2023
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Jaw Repositioning
- Device Class
- Class II
- Regulation Number
- 872.5570
- Review Panel
- DE
- Submission Type