510(k) K233754
K233754 is an FDA 510(k) premarket notification submitted by Aiomega, LLC for the device "AIO Breathe". The FDA issued a decision of Substantially Equivalent on February 23, 2024. The device falls under product code LQZ (Device, Jaw Repositioning), a Class II device regulated under 21 CFR 872.5570. Aiomega, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 2024
- Date Received
- November 22, 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