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

    MODEL FB-20 NON-INVASIVE BLOOD PRESSURE MONITOR

    K Number: K861504 · Decision Aug 25, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    68
    Review Days
    124

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    Basic Information

    Device Name
    MODEL FB-20 NON-INVASIVE BLOOD PRESSURE MONITOR
    K Number
    K861504
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Fukuda Denshi USA, Inc.
    Date Received
    April 23, 1986
    Decision Date
    August 25, 1986
    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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