| K-number | K080880 |
| Device name | RTM AND OVAL |
| Applicant | Next Mobility, LLC |
| Product code | IOR |
| Device class | Class I |
| Decision date | Apr 9, 2008 |
| Decision | Substantially Equivalent |
| Regulation | 890.3850 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov