GE STERILE DISPOSABLE EQUIPMENT COIL COVER

GE STERILE DISPOSABLE EQUIPMENT COIL COVER is an FDA 510(k)-cleared medical device (K964141) manufactured by Contour Fabricators, 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 January 29, 1997. Regulation: 8.