ClearanceBrief
510(k) K160573 ยท LHQ System, Telethermographic (Adjunctive Use)

FirstSense Breast Exam

ApplicantFirst Sense Medical, LLC, Pontiac MI, US
DecisionSubstantially Equivalent, Jun 1, 2016
ReceivedFeb 29, 2016
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K160573

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.