510(k) K241051

Vave Wireless Ultrasound System by Vave Health, Inc. — Product Code IYN

K241051 is an FDA 510(k) premarket notification submitted by Vave Health, Inc. for the device "Vave Wireless Ultrasound System". The FDA issued a decision of Substantially Equivalent on Aug 30, 2024. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Vave Health, Inc. has at least 1 other 510(k) clearance on record.