ClearanceBrief
510(k) K210484 ยท MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)

LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System

ApplicantMedtronic, Inc., Mounds View MN, US
DecisionSubstantially Equivalent, Jun 11, 2021
ReceivedFeb 19, 2021
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K210484

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.