MODIFICATION OF: RHEO DOPPLEX II

MODIFICATION OF: RHEO DOPPLEX II is an FDA 510(k)-cleared medical device (K984307) manufactured by Huntleigh Healthcare, 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 11, 1999. Regulation: 8.