The following data is part of a premarket notification filed by Owandy with the FDA for Opteo, Videograph Hd.
| Device ID | K133271 |
| 510k Number | K133271 |
| Device Name: | OPTEO, VIDEOGRAPH HD |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | OWANDY 110 EAST GRANADA BLVD, SUITE 207 Ormond Beach, FL 32176 |
| Contact | Claude Berthoin |
| Correspondent | Claude Berthoin OWANDY 110 EAST GRANADA BLVD, SUITE 207 Ormond Beach, FL 32176 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-24 |
| Decision Date | 2014-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08052870660916 | K133271 | 000 |
| 08052870660817 | K133271 | 000 |
| 03760262652351 | K133271 | 000 |
| 03760262652337 | K133271 | 000 |
| 03760262651125 | K133271 | 000 |
| 03760262651118 | K133271 | 000 |
| 03760262651026 | K133271 | 000 |
| 03760262651019 | K133271 | 000 |
| 03760262650814 | K133271 | 000 |