The following data is part of a premarket notification filed by Centervue Spa with the FDA for Centervue Macular Integrity Assessment.
| Device ID | K133758 |
| 510k Number | K133758 |
| Device Name: | CENTERVUE MACULAR INTEGRITY ASSESSMENT |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | CENTERVUE SPA PIAZZA ALBANIA 10 Rome, IT 00153 |
| Contact | Roger Gray |
| Correspondent | Roger Gray CENTERVUE SPA PIAZZA ALBANIA 10 Rome, IT 00153 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-11 |
| Decision Date | 2014-04-23 |
| Summary: | summary |