COCHLEAR BAHA BP100

COCHLEAR BAHA BP100 is an FDA 510(k)-cleared medical device (K090720) manufactured by Cochlear Bone Anchored Systems AB. 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 16, 2009. Regulation: 8.