510(k) K241662

Ultrasound Transducer Cover by Vitrolife Sweden AB — Product Code ITX

K241662 is an FDA 510(k) premarket notification submitted by Vitrolife Sweden AB for the device "Ultrasound Transducer Cover". The FDA issued a decision of Substantially Equivalent on August 30, 2024. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Vitrolife Sweden AB has at least 10 other 510(k) clearances on record.