NICOLET REAL EAR ANALYZER

NICOLET REAL EAR ANALYZER is an FDA 510(k)-cleared medical device (K896477) manufactured by Nicolet Instrument Corp.. 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 February 7, 1990. Regulation: 8.