ClearanceBrief
510(k) K182907 ยท IZI System, X-Ray, Angiographic

SPY Elite Intraoperative Perfusion Assessment System

ApplicantNovadaq Technologies Ulc. (Now A Part of Stryker), Burnaby, CA
DecisionSubstantially Equivalent, Jan 23, 2019
ReceivedOct 17, 2018
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K182907

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.