The following data is part of a premarket notification filed by Institut Georges Lopez with the FDA for Rm4 Control Unit.
| Device ID | K211224 |
| 510k Number | K211224 |
| Device Name: | RM4 Control Unit |
| Classification | System, Perfusion, Kidney |
| Applicant | Institut Georges Lopez Parc Tertiaire Du Bois Dieu, 1 Allee Des Chevreuils Lissieu, FR 69380 |
| Contact | Matthieu Prouteau |
| Correspondent | Matthieu Prouteau Institut Georges Lopez Parc Tertiaire Du Bois Dieu, 1 Allee Des Chevreuils Lissieu, FR 69380 |
| Product Code | KDN |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-23 |
| Decision Date | 2021-10-15 |