510(k) K232735
K232735 is an FDA 510(k) premarket notification submitted by Ema Sleep Incorporated for the device "EMA 3D". The FDA issued a decision of Substantially Equivalent on May 3, 2024. 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
- May 3, 2024
- Date Received
- September 7, 2023
- Clearance Type
- Traditional
- 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