TMO-1000, TMO-3000, TMO-10,000 NON-INVAS. THERMO.

TMO-1000, TMO-3000, TMO-10,000 NON-INVAS. THERMO. is an FDA 510(k)-cleared medical device (K871529) manufactured by Western Medical Equipment Corp.. 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 October 21, 1987. Regulation: 8.