PROFILE 7000 C-SPINE COIL

PROFILE 7000 C-SPINE COIL is an FDA 510(k)-cleared medical device (K943440) manufactured by Us Asia Instruments, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 5, 1995. Regulation: 8.