K854872 is an FDA 510(k) clearance for the VFI/VFE SYSTEM II..
Submitted by Mira, Inc. (Waltham, US). The FDA issued a Cleared decision on February 13, 1986, 71 days after receiving the submission on December 4, 1985.
This device falls under the Ophthalmic FDA review panel.
| 510(k) Number | K854872 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent — Traditional 510(k) (SESE) |
| Date Received | December 04, 1985 |
| Decision Date | February 13, 1986 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | — |
| Device Class | — |