HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER

HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER is an FDA 510(k)-cleared medical device (K902068) manufactured by Starkey Laboratories, 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 August 5, 1990. Regulation: 8.