ClearanceBrief
510(k) K183116 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Unity Network ID

ApplicantGE Healthcare, Milwaukee WI, US
DecisionSubstantially Equivalent, Dec 6, 2018
ReceivedNov 9, 2018
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K183116

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.