Tetra (TM-20); Tetra (TM-50)

Tetra (TM-20); Tetra (TM-50) is an FDA 510(k)-cleared medical device (K251105) manufactured by Emed Technologies 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 December 21, 2025. Regulation: 8.