ClearanceBrief
510(k) K170521 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic

TRINITY/3D PROSTATE SUITE

ApplicantKoelis, Meylan, FR
DecisionSubstantially Equivalent, May 30, 2017
ReceivedFeb 22, 2017
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K170521

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.