ClearanceBrief
510(k) K963065 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic

CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS

ApplicantShantou Institute of Ultrasonic Instuments, Walnut Creek CA, US
DecisionSubstantially Equivalent, May 29, 1997
ReceivedAug 7, 1996
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K963065

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.