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    FDA 510(k) FDA class 3 Substantially Equivalent 🇯🇵 Japan

    HOME BLOOD PRESSURE KIT, ANEROID

    K Number: K884420 · Decision Aug 25, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    460
    Applicant Total
    2
    Review Days
    309

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    Basic Information

    Device Name
    HOME BLOOD PRESSURE KIT, ANEROID
    K Number
    K884420
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Yamasu Co. , Ltd.
    Date Received
    October 20, 1988
    Decision Date
    August 25, 1989
    Product Code
    DXY
    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
    DXY Implantable Pacemaker Pulse-Generator

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