510(k) K904901

L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC by Parexel Intl. Corp. — Product Code ITX

K904901 is an FDA 510(k) premarket notification submitted by Parexel Intl. Corp. for the device "L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC". The FDA issued a decision of Substantially Equivalent on March 26, 1991. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Parexel Intl. Corp. has at least 10 other 510(k) clearances on record.