ClearanceBrief
510(k) K181336 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic

HS50 / HS60 Diagnostic Ultrasound System

ApplicantSamsung Medison Co., Ltd., Hongcheon-Gun, KR
DecisionSubstantially Equivalent, Dec 4, 2018
ReceivedMay 21, 2018
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K181336

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.