510(k) K202499
K202499 is an FDA 510(k) premarket notification submitted by Diamond Orthotic Laboratory for the device "Diamond Digital Sleep Orthotic (DDSO)". The FDA issued a decision of Substantially Equivalent on Sep 3, 2020. 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
- Sep 3, 2020
- Date Received
- Aug 31, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Device, Anti-Snoring
- Device Class
- Class II
- Regulation Number
- 872.5570
- Review Panel
- DE
- Submission Type
- 510(k)