ClearanceBrief
510(k) K132466 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic

MYLABSEVEN 6400, MYLABALPHA 7400

ApplicantEsaote, S.p.A., Indianpolis IN, US
DecisionSubstantially Equivalent, Dec 4, 2013
ReceivedAug 7, 2013
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K132466

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.