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

    Avologi Gel Primer (Model: Av25)

    K Number: K220735 · Decision Sep 15, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    68
    Applicant Total
    6
    Review Days
    550

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    Basic Information

    Device Name
    Avologi Gel Primer (Model: Av25)
    K Number
    K220735
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1275
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Premier North America, Inc.
    Date Received
    March 14, 2022
    Decision Date
    September 15, 2023
    Product Code
    GYB
    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
    GYB Media, Electroconductive

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