The following data is part of a premarket notification filed by Olea Medical Sas with the FDA for Functional Mr V1.0.
| Device ID | K221426 |
| 510k Number | K221426 |
| Device Name: | Functional MR V1.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | Olea Medical SAS 93 Avenue Des Sorbiersm ZI ATHELIA IV La Ciotat, FR 13600 |
| Contact | Nathalie Palumbo |
| Correspondent | John J. Smith Hogan Lovells US LLP Columbia Square 555 Thirteenth Street NW Washington, DC 20004 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-16 |
| Decision Date | 2022-07-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EOLEFMRIV1P00 | K221426 | 000 |