510(k) K903984

CW DOPPLER/4.5 MHZ by Diasonics, Inc. — Product Code ITX

K903984 is an FDA 510(k) premarket notification submitted by Diasonics, Inc. for the device "CW DOPPLER/4.5 MHZ". The FDA issued a decision of Substantially Equivalent on June 14, 1991. 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.