BIOBOX TRAPTOP (SMALL, MEDIUM, LARGE AND X-LARGE)

BIOBOX TRAPTOP (SMALL, MEDIUM, LARGE AND X-LARGE) is an FDA 510(k)-cleared medical device (K950897) manufactured by Biosystems. 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 August 23, 1995. Regulation: 8.