510(k) K905200

SACA, 3.5 MHZ PROBE by Diasonics, Inc. — Product Code ITX

K905200 is an FDA 510(k) premarket notification submitted by Diasonics, Inc. for the device "SACA, 3.5 MHZ PROBE". The FDA issued a decision of Substantially Equivalent on April 2, 1992. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Diasonics, Inc. has at least 10 other 510(k) clearances on record.