ClearanceBrief
510(k) K161717 ยท GYD Transducer, Tremor

Personal Kinetigraph (PKG) System

ApplicantGkc Manufacturing Pty, Ltd., Melbourne, AU
DecisionSubstantially Equivalent, Sep 20, 2016
ReceivedJun 22, 2016
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K161717

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.