ClearanceBrief
510(k) K163065 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

T3 Software

ApplicantEtiometry, Inc., Boston MA, US
DecisionSubstantially Equivalent, May 26, 2017
ReceivedNov 2, 2016
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K163065

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.