ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105

ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 is an FDA 510(k)-cleared medical device (K080622) manufactured by Optim, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 1, 2008. Regulation: 8.