OTOACOUSTIC EMISSIONS UNIT CELESTA 503

OTOACOUSTIC EMISSIONS UNIT CELESTA 503 is an FDA 510(k)-cleared medical device (K931325) 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 February 17, 1994. Regulation: 8.