The following data is part of a premarket notification filed by Stephanix with the FDA for Movix Dreamy.
| Device ID | K212515 |
| 510k Number | K212515 |
| Device Name: | MOVIX DReamy |
| Classification | System, X-ray, Mobile |
| 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 | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-10 |
| Decision Date | 2021-11-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03664049902496 | K212515 | 000 |
| 03664049902489 | K212515 | 000 |
| 03664049902472 | K212515 | 000 |
| 03664049902366 | K212515 | 000 |