BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM

    K Number: K051368 · Decision Aug 9, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    16
    Review Days
    76

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    Basic Information

    Device Name
    BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM
    K Number
    K051368
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Schiller AG
    Date Received
    May 25, 2005
    Decision Date
    August 9, 2005
    Product Code
    DXN
    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
    DXN System, Measurement, Blood-Pressure, Non-Invasive

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