ClearanceBrief
510(k) K113007 ยท JQP Calculator/Data Processing Module, For Clinical Use

BIONIME DIABETES MANAGEMENT SYSTEM VI.0

ApplicantBionime Corporation, Mission Viejo CA, US
DecisionSubstantially Equivalent, Feb 27, 2012
ReceivedOct 7, 2011
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K113007

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.