510(k) K080234

TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO by Teratech Corp. — Product Code IYO

K080234 is an FDA 510(k) premarket notification submitted by Teratech Corp. for the device "TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO". The FDA issued a decision of Substantially Equivalent on Feb 14, 2008. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Teratech Corp. has 16 other 510(k) clearances on record.