ClearanceBrief
510(k) K161062 ยท MWJ Electrocardiograph, Ambulatory (Without Analysis)

NR Recorder

ApplicantNorav Medical GmbH, Wiesbaden, DE
DecisionSubstantially Equivalent, Jun 13, 2016
ReceivedApr 15, 2016
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K161062

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.