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    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110

    K Number: K012194 · Decision Jul 20, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    197
    Applicant Total
    21
    Review Days
    7

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    Basic Information

    Device Name
    BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110
    K Number
    K012194
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nihon Seimitsu Sokki Co., Ltd.
    Date Received
    July 13, 2001
    Decision Date
    July 20, 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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    Other Clearances by Nihon Seimitsu Sokki Co., Ltd.

    K Number Device Name
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    Search all 21 clearances from Nihon Seimitsu Sokki Co., Ltd. →