510(k) K163138

Clarius Ultrasound System by Clarius Mobile Health Corp. — Product Code IYN

K163138 is an FDA 510(k) premarket notification submitted by Clarius Mobile Health Corp. for the device "Clarius Ultrasound System". The FDA issued a decision of Substantially Equivalent on Nov 30, 2016. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Clarius Mobile Health Corp. has at least 10 other 510(k) clearances on record.