510(k) K902728

7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815) by Ausonics Pty , Ltd. — Product Code ITX

K902728 is an FDA 510(k) premarket notification submitted by Ausonics Pty , Ltd. for the device "7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815)". The FDA issued a decision of Substantially Equivalent on February 13, 1991. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Ausonics Pty , Ltd. has at least 10 other 510(k) clearances on record.