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

    Ampa One System (AMPA-001)

    K Number: K243319 · Decision Feb 13, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    65
    Applicant Total
    2
    Review Days
    113

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    Basic Information

    Device Name
    Ampa One System (AMPA-001)
    K Number
    K243319
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5805
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neuromodulatory Devices & Applications
    Date Received
    October 23, 2024
    Decision Date
    February 13, 2025
    Product Code
    OBP
    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
    OBP Transcranial Magnetic Stimulator

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    Other Clearances by Neuromodulatory Devices & Applications

    K Number Device Name
    K251210 Ampa One System (AMPA-001)