510(k) K141806

CLEAR GUIDE ONE by Clear Guide Medical — Product Code IYO

K141806 is an FDA 510(k) premarket notification submitted by Clear Guide Medical for the device "CLEAR GUIDE ONE". The FDA issued a decision of Substantially Equivalent on September 19, 2014. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Clear Guide Medical has at least 5 other 510(k) clearances on record.