| K-number | K222198 |
| Device name | Exo Iris (El2001) |
| Applicant | Exo Imaging, Inc. |
| Product code | IYN |
| Device class | Class II |
| Decision date | Nov 9, 2022 |
| Decision | Substantially Equivalent |
| Regulation | 892.1550 |
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