MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS

MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS is an FDA 510(k)-cleared medical device (K092244) manufactured by Diagnostic Group, LLC. 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 28, 2010. Regulation: 8.