510(k) K940671

INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND FLOWMETER by Interspec, Inc. — Product Code ITX

K940671 is an FDA 510(k) premarket notification submitted by Interspec, Inc. for the device "INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND FLOWMETER". The FDA issued a decision of Substantially Equivalent on November 22, 1994. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Interspec, Inc. has at least 10 other 510(k) clearances on record.