510(k) K991805

ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION by Acuson Corp. — Product Code IYN

K991805 is an FDA 510(k) premarket notification submitted by Acuson Corp. for the device "ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION". The FDA issued a decision of Substantially Equivalent on August 2, 1999. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Acuson Corp. has at least 10 other 510(k) clearances on record.