K133758 is an FDA 510(k) clearance for the CENTERVUE MACULAR INTEGRITY ASSESSMENT. This device is classified as a Ophthalmoscope, Ac-powered (Class II - Special Controls, product code HLI).
Submitted by Centervue S.P.A. (Rome, IT). The FDA issued a Cleared decision on April 23, 2014, 133 days after receiving the submission on December 11, 2013.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570.
| 510(k) Number | K133758 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2013 |
| Decision Date | April 23, 2014 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HLI — Ophthalmoscope, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1570 |