AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101

AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101 is an FDA 510(k)-cleared medical device (K042906) manufactured by Amplife Corporation. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 18, 2004. Regulation: 8.