RESPIRATION/APNEA AMPLIFIER MODEL 3105

RESPIRATION/APNEA AMPLIFIER MODEL 3105 is an FDA 510(k)-cleared medical device (K792528) manufactured by Electronics For Medicine, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 20, 1980. Regulation: 8.