510(k) K160234
K160234 is an FDA 510(k) premarket notification submitted by Oventus Manufacturing Pty, Ltd. for the device "OVENT". The FDA issued a decision of Substantially Equivalent on Mar 17, 2016. 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
- Mar 17, 2016
- Date Received
- Feb 1, 2016
- 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)