The following data is part of a premarket notification filed by Owandy Sas with the FDA for Universal-x (usa) Or /krystal-x (europe).
| Device ID | K053172 |
| 510k Number | K053172 |
| Device Name: | UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE) |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | OWANDY SAS 1251 AVENUE OF THE AMERICAS 34TH FLOOR New York, NY 10020 |
| Contact | Olivier Maurier |
| Correspondent | Olivier Maurier OWANDY SAS 1251 AVENUE OF THE AMERICAS 34TH FLOOR New York, NY 10020 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-14 |
| Decision Date | 2006-06-09 |
| Summary: | summary |