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

    GSIBP BLOOD PRESSURE CUFF

    K Number: K012553 · Decision Aug 17, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    197
    Applicant Total
    1
    Review Days
    9

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    Basic Information

    Device Name
    GSIBP BLOOD PRESSURE CUFF
    K Number
    K012553
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Globalshop, Inc.
    Date Received
    August 8, 2001
    Decision Date
    August 17, 2001
    Product Code
    DXQ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    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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