ClearanceBrief
510(k) K220446 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic

Versana Balance

ApplicantGE Medical Systems Ultrasound and Primary Care Diagnostics, Wauwatosa WI, US
DecisionSubstantially Equivalent, May 11, 2022
ReceivedFeb 16, 2022
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K220446

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.