IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM

IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K854330) manufactured by Par Technology Park. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 12, 1985. Regulation: 8.