The following data is part of a premarket notification filed by Stephanix with the FDA for D²rs And D²rs 9090.
| Device ID | K213479 |
| 510k Number | K213479 |
| Device Name: | D²RS And D²RS 9090 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Stephanix 10, Rue Jean Moulin Z.I Du Bayon La Ricamarie, FR 42150 |
| Contact | Sandie Perret |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | OWB |
| Subsequent Product Code | IZI |
| Subsequent Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-29 |
| Decision Date | 2021-12-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03664049001052 | K213479 | 000 |
| 03664049001038 | K213479 | 000 |
| 03664049000055 | K213479 | 000 |
| 03664049000031 | K213479 | 000 |