BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    AViTA Arm Type Blood Pressure Monitor Cuff

    K Number: K250765 · Decision Sep 3, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    197
    Applicant Total
    27
    Review Days
    174

    Basic Information

    Device Name
    AViTA Arm Type Blood Pressure Monitor Cuff
    K Number
    K250765
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Avita Corporation
    Date Received
    March 13, 2025
    Decision Date
    September 3, 2025
    Product Code
    DXQ
    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
    DXQ Blood Pressure Cuff

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