The following data is part of a premarket notification filed by Oventus Manufacturing Pty Ltd with the FDA for O2vent T.
| Device ID | K161832 |
| 510k Number | K161832 |
| Device Name: | O2VENT T |
| 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 | 2016-07-05 |
| Decision Date | 2016-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09351567000011 | K161832 | 000 |