IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P

IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P is an FDA 510(k)-cleared medical device (K894748) manufactured by Singer Medical Products, 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 December 4, 1989. Regulation: 8.