510(k) K020754

NICOLET PIONEER TC8080 by Nicolet Biomedical — Product Code IYN

K020754 is an FDA 510(k) premarket notification submitted by Nicolet Biomedical for the device "NICOLET PIONEER TC8080". The FDA issued a decision of Substantially Equivalent on April 21, 2003. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Nicolet Biomedical has at least 10 other 510(k) clearances on record.