510(k) K894054

5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER by Advanced Technology Laboratories, Inc. — Product Code IYN

K894054 is an FDA 510(k) premarket notification submitted by Advanced Technology Laboratories, Inc. for the device "5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER". The FDA issued a decision of Substantially Equivalent on September 12, 1989. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Advanced Technology Laboratories, Inc. has at least 10 other 510(k) clearances on record.