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

    OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM403C

    K Number: K881601 · Decision Jun 15, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    7
    Review Days
    63

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    Basic Information

    Device Name
    OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM403C
    K Number
    K881601
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Omron Tateisi Electronics Co.
    Date Received
    April 13, 1988
    Decision Date
    June 15, 1988
    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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    Other Clearances by Omron Tateisi Electronics Co.

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    K854201 OMRON DIGITAL BP MONITOR HEM-700CP
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