MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM

MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM is an FDA 510(k)-cleared medical device (K872633) manufactured by Hearing Health Care Program. 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 September 15, 1987. Regulation: 8.