MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN)

MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN) is an FDA 510(k)-cleared medical device (K852334) manufactured by Design Med. Corp.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 17, 1985. Regulation: 8.