The following data is part of a premarket notification filed by Oventus Manufacturing Pty Ltd with the FDA for O2vent Optima.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
09351567000035 | K190236 | 000 |
09351567000363 | K190236 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
O2VENT OPTIMA 79250334 not registered Live/Pending |
Oventus Medical Limited 2018-12-19 |