ClearanceBrief
510(k) K210416 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic

M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System

ApplicantShenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, CN
DecisionSubstantially Equivalent, Jun 10, 2021
ReceivedFeb 11, 2021
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K210416

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.