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

    XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES

    K Number: K112426 · Decision Apr 2, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    96
    Applicant Total
    2
    Review Days
    223

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    Basic Information

    Device Name
    XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES
    K Number
    K112426
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1820
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xian Friendship Medical Electronics Co., Ltd.
    Date Received
    August 23, 2011
    Decision Date
    April 2, 2012
    Product Code
    ETN
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ETN Stimulator, Nerve

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    Other Clearances by Xian Friendship Medical Electronics Co., Ltd.

    K Number Device Name
    K110289 FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE