510(k) K990400

LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM by Hewlett-Packard Co. — Product Code ITX

K990400 is an FDA 510(k) premarket notification submitted by Hewlett-Packard Co. for the device "LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on February 24, 1999. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Hewlett-Packard Co. has at least 10 other 510(k) clearances on record.