510(k) K993398

ECHO VIEW, EASY VIEW, OMNI VIEW by Tomtec Imaging Systems GmbH — Product Code IYO

K993398 is an FDA 510(k) premarket notification submitted by Tomtec Imaging Systems GmbH for the device "ECHO VIEW, EASY VIEW, OMNI VIEW". The FDA issued a decision of Substantially Equivalent on November 5, 1999. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Tomtec Imaging Systems GmbH has at least 10 other 510(k) clearances on record.