O2Vent Optima
Device, Anti-snoring
Oventus Manufacturing PTY LTD
The following data is part of a premarket notification filed by Oventus Manufacturing Pty Ltd with the FDA for O2vent Optima.
Pre-market Notification Details
| Device ID | K190236 |
| 510k Number | K190236 |
| Device Name: | O2Vent Optima |
| Classification | Device, Anti-snoring |
| Applicant | Oventus Manufacturing PTY LTD 1 Swann Road Indooroopilly, AU 4068 |
| Contact | Robyn Woidtke |
| Correspondent | M.w. (andy) Anderson Regulatory And Clinical Research Institute 5353 Wayzata Blvd, Ste 505 Minneapolis, MN 55416 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-06 |
| Decision Date | 2019-08-29 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09351567000035 | K190236 | 000 |
| 09351567000363 | K190236 | 000 |
Trademark Results [O2Vent Optima]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 O2VENT OPTIMA 79250334 not registered Live/Pending |
Oventus Medical Limited 2018-12-19 |
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