ClearanceBrief
510(k) K083061 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic

ELLEX INNOVATIVE IMAGING EYE CUBED V4

ApplicantEllex, Inc., Sacramento CA, US
DecisionSubstantially Equivalent, Jan 9, 2009
ReceivedOct 14, 2008
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K083061

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.