The following data is part of a premarket notification filed by Oventus Manufacturing Pty Ltd with the FDA for O2vent W.
| Device ID | K171316 |
| 510k Number | K171316 |
| Device Name: | O2Vent W |
| Classification | Device, Anti-snoring |
| Applicant | Oventus Manufacturing Pty Ltd 1 Swann Road Indooroopilly, AU 4068 |
| Contact | Hemangi Malde |
| Correspondent | M.w. Andy Anderson Regulatory And Clinical Research Institute, Inc. 5353 Wayzata Boulevard, #505 Minneapolis, MN 55416 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-04 |
| Decision Date | 2017-07-11 |
| Summary: | summary |