ClearanceBrief
510(k) K211665 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic

SONON Ultrasound Imaging System, Model: SONON300C

ApplicantHealcerion Co., Ltd., Seoul, KR
DecisionSubstantially Equivalent, May 16, 2022
ReceivedJun 1, 2021
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K211665

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.