ZODIAC 901 MIDDLE-EAR ANALYZER

ZODIAC 901 MIDDLE-EAR ANALYZER is an FDA 510(k)-cleared medical device (K910247) manufactured by Madsen Electronics (Canada) , Ltd.. 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 June 18, 1991. Regulation: 8.