SACA, 3.5 MHZ PROBE

SACA, 3.5 MHZ PROBE is an FDA 510(k)-cleared medical device (K905200) manufactured by Diasonics, 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 April 1, 1992. Regulation: 8.