The following data is part of a premarket notification filed by Cefla S.c. with the FDA for Myray Skyview.
| Device ID | K081088 |
| 510k Number | K081088 |
| Device Name: | MYRAY SKYVIEW |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | CEFLA S.C. 110 E. GRANADA BLVD. SUITE 207 Ormond Beach, FL 32176 |
| Contact | Berthoin Claude |
| Correspondent | Berthoin Claude CEFLA S.C. 110 E. GRANADA BLVD. SUITE 207 Ormond Beach, FL 32176 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-16 |
| Decision Date | 2008-11-06 |