510(k) K911166

DIAGNOSTIC ULTRASOUND/URO-GYN UD 511 by Diagnostic Ultrasound Corp. — Product Code DXT

K911166 is an FDA 510(k) premarket notification submitted by Diagnostic Ultrasound Corp. for the device "DIAGNOSTIC ULTRASOUND/URO-GYN UD 511". The FDA issued a decision of Substantially Equivalent on August 15, 1991. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Diagnostic Ultrasound Corp. has at least 10 other 510(k) clearances on record.