BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    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))

    K Number: DEN230076 · Decision Oct 8, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    68
    Review Days
    330

    Basic Information

    Device Name
    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))
    K Number
    DEN230076
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    870.1135
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Applicant
    Omron Healthcare, Inc.
    Date Received
    November 13, 2023
    Decision Date
    October 8, 2024
    Product Code
    QXY
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QXY Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature

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