ClearanceBrief
510(k) DEN230076 ยท QXY Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature

Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ))

ApplicantOmron Healthcare, Inc., Hoffman Estates IL, US
DecisionUnknown, Oct 8, 2024
ReceivedNov 13, 2023
TypeDirect
FDA recordOpen on fda.gov

Recalls that name DEN230076

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.