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

    Electro Auricular Device

    K Number: K140530 · Decision Oct 2, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    212

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    Basic Information

    Device Name
    Electro Auricular Device
    K Number
    K140530
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Navigant Consulting, Inc.
    Date Received
    March 4, 2014
    Decision Date
    October 2, 2014
    Product Code
    BWK
    Advisory Committee
    Unknown
    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
    BWK Stimulator, Electro-Acupuncture

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