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

    NET Recovery Corp/NET Device

    K Number: K233166 · Decision May 29, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    245

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    Basic Information

    Device Name
    NET Recovery Corp/NET Device
    K Number
    K233166
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5896
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Net Recovery
    Date Received
    September 27, 2023
    Decision Date
    May 29, 2024
    Product Code
    PZR
    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
    PZR Percutaneous Nerve Stimulator For Opioid Withdrawal

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