The following data is part of a premarket notification filed by Medovations, Inc. with the FDA for Oxygen Catheters.
| Device ID | K830984 |
| 510k Number | K830984 |
| Device Name: | OXYGEN CATHETERS |
| Classification | Catheter, Nasal, Oxygen |
| Applicant | MEDOVATIONS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZB |
| CFR Regulation Number | 868.5350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-29 |
| Decision Date | 1983-05-18 |