510(k) K190236
K190236 is an FDA 510(k) premarket notification submitted by Oventus Manufacturing Pty, Ltd. for the device "O2Vent Optima". The FDA issued a decision of Substantially Equivalent on Aug 29, 2019. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570. Oventus Manufacturing Pty, Ltd. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 29, 2019
- Date Received
- Feb 6, 2019
- 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
- 510(k)