K854870 is an FDA 510(k) clearance for the INTRAOCULAR ELECTROMAGNET. This device is classified as a Magnet, Ac-powered (Class II - Special Controls, product code HPO).
Submitted by Mira, Inc. (Waltham, US). The FDA issued a Cleared decision on February 19, 1986, 77 days after receiving the submission on December 4, 1985.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4440.
| 510(k) Number | K854870 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 1985 |
| Decision Date | February 19, 1986 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HPO — Magnet, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4440 |