BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PULSATRON NERVE LOCATOR/STIMULATOR

    K Number: K833646 · Decision Feb 10, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    96
    Applicant Total
    140
    Review Days
    116

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    Basic Information

    Device Name
    PULSATRON NERVE LOCATOR/STIMULATOR
    K Number
    K833646
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1820
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Edward Weck, Inc.
    Date Received
    October 17, 1983
    Decision Date
    February 10, 1984
    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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