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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Electronic Pulse Stimulator

    K Number: K160508 · Decision Nov 21, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    29
    Review Days
    271

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    Basic Information

    Device Name
    Electronic Pulse Stimulator
    K Number
    K160508
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beijing Choice Electronic Technololgy Co., Ltd.
    Date Received
    February 24, 2016
    Decision Date
    November 21, 2016
    Product Code
    NUH
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

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    Other Clearances by Beijing Choice Electronic Technololgy Co., Ltd.

    K Number Device Name
    K151206 Fingertip Pulse Oximeter
    K142888 Fingertip Pulse Oximeter
    K141024 EXTERNAL PULSE OXIMETER
    K141128 FINGERTIP PULSE OXIMETER
    K140682 FINGERTIP PULSE OXIMETER
    K131047 FINGERTIP PULSE OXIMETER
    K130947 FINGERTIP PULSE OXIMETER
    K123871 FINGERTIP PULSE OXIMETER
    K122046 WRIST PULSE OXIMETER
    K112622 HANDHELD ECG MONITOR
    Search all 29 clearances from Beijing Choice Electronic Technololgy Co., Ltd. →