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

    DIGITAL SPHYGMOMANOMETER

    K Number: K871371 · Decision Jun 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    147
    Applicant Total
    7
    Review Days
    66

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    Basic Information

    Device Name
    DIGITAL SPHYGMOMANOMETER
    K Number
    K871371
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2850
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Omron Tateisi Electronics Co.
    Date Received
    April 7, 1987
    Decision Date
    June 12, 1987
    Product Code
    DRS
    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
    DRS Transducer, Blood-Pressure, Extravascular

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    Other Clearances by Omron Tateisi Electronics Co.

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    K864466 OMRON ULTRASONIC NEBULIZER MODEL NE-UO5
    K854201 OMRON DIGITAL BP MONITOR HEM-700CP
    K853260 OMRON DIGITAL BP MONITOR HEM-700C
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