FLOSTAT VASCULAR REPORT GENERATOR (VRG)

FLOSTAT VASCULAR REPORT GENERATOR (VRG) is an FDA 510(k)-cleared medical device (K973857) manufactured by Biomedix, 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 December 28, 1997. Regulation: 8.