ClearanceBrief
510(k) K161686 ยท BZD Ventilator, Non-Continuous (Respirator)

F&P InfoSmart

ApplicantFisher & Paykel Healthcare, Ltd., Auckland, NZ
DecisionSubstantially Equivalent, Jan 24, 2017
ReceivedJun 17, 2016
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K161686

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.