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

    PANTHEON ELECTROSTIMULATOR

    K Number: K133980 · Decision Nov 7, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    315

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    Basic Information

    Device Name
    PANTHEON ELECTROSTIMULATOR
    K Number
    K133980
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pantheon Research
    Date Received
    December 27, 2013
    Decision Date
    November 7, 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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