The following data is part of a premarket notification filed by Sopro with the FDA for S575 Intraoral Docking Dental Camera.
| Device ID | K990948 |
| 510k Number | K990948 |
| Device Name: | S575 INTRAORAL DOCKING DENTAL CAMERA |
| Classification | Unit, Operative Dental |
| Applicant | SOPRO PLACE ST. CHRISTOPHE LES ACCATES-LA VALENTINE Marseille, FR 13011 |
| Contact | Pierre Montillot |
| Correspondent | Pierre Montillot SOPRO PLACE ST. CHRISTOPHE LES ACCATES-LA VALENTINE Marseille, FR 13011 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-22 |
| Decision Date | 1999-04-21 |
| Summary: | summary |