510(k) K240427
K240427 is an FDA 510(k) premarket notification submitted by Gelb Practice Solutions, Inc. for the device "airVata". The FDA issued a decision of Substantially Equivalent on February 14, 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
- February 14, 2024
- Date Received
- February 13, 2024
- 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