510(k) K210203
K210203 is an FDA 510(k) premarket notification submitted by Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I) for the device "mmRNA appliance". The FDA issued a decision of Substantially Equivalent on Aug 19, 2021. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 19, 2021
- Date Received
- Jan 26, 2021
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Anti-Snoring
- Device Class
- Class II
- Regulation Number
- 872.5570
- Review Panel
- DE
- Submission Type
- 510(k)