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

    OMRON DIGITAL BP MONITOR HEM-700C

    K Number: K853260 · Decision Nov 18, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    7
    Review Days
    108

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    Basic Information

    Device Name
    OMRON DIGITAL BP MONITOR HEM-700C
    K Number
    K853260
    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
    August 2, 1985
    Decision Date
    November 18, 1985
    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.

    K Number Device Name
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    K871371 DIGITAL SPHYGMOMANOMETER
    K864466 OMRON ULTRASONIC NEBULIZER MODEL NE-UO5
    K854201 OMRON DIGITAL BP MONITOR HEM-700CP
    K851707 OMRON DIGITAL BP MONITOR HEM-400C