ClearanceBrief
510(k) K190769 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic

Bladder Scanner (Models: M2, M2-W, M1, M1-W)

ApplicantSuzhou Lischka Medtech Co., Ltd., Kunshan, CN
DecisionSubstantially Equivalent, May 22, 2019
ReceivedMar 26, 2019
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K190769

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.