MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT

MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT is an FDA 510(k)-cleared medical device (K002044) manufactured by Magna Fortis Corporation. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 11, 2000. Regulation: 8.