7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815)

7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815) is an FDA 510(k)-cleared medical device (K902728) manufactured by Ausonics Pty , Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 12, 1991. Regulation: 8.