510(k) K230472

Sonopuls 190 by Enraf-Nonius, B.V. — Product Code IMI

K230472 is an FDA 510(k) premarket notification submitted by Enraf-Nonius, B.V. for the device "Sonopuls 190". The FDA issued a decision of Substantially Equivalent on October 24, 2023. The device falls under product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5300. Enraf-Nonius, B.V. has at least 4 other 510(k) clearances on record.