SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE

SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE is an FDA 510(k)-cleared medical device (K101244) manufactured by Truer Medical, Inc.. 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 17, 2010. Regulation: 8.