510(k) K233955

Clarius OB AI by Clarius Mobile Health Corp. — Product Code IYN

K233955 is an FDA 510(k) premarket notification submitted by Clarius Mobile Health Corp. for the device "Clarius OB AI". The FDA issued a decision of Substantially Equivalent on Jun 14, 2024. 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.