510(k) K213436

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

K213436 is an FDA 510(k) premarket notification submitted by Clarius Mobile Health Corp. for the device "Clarius Ultrasound Scanner". The FDA issued a decision of Substantially Equivalent on Nov 15, 2021. 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.