510(k) K202788

Sonomed IV, Sonomed V by Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto — Product Code IMI

K202788 is an FDA 510(k) premarket notification submitted by Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto for the device "Sonomed IV, Sonomed V". The FDA issued a decision of Substantially Equivalent on December 23, 2021. 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.