BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NEUROPACE

    Reg #: 3004426659 · FEI: 3004426659 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

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    Registration Details

    Registration Name
    NEUROPACE
    Registration Number
    3004426659
    FEI Number
    3004426659
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    455 N. Bernardo Avenue
    City
    Mountain View
    State
    CA
    ZIP
    94043
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141368
    PMA Number
    P100026

    Owner / Operator

    Firm Name
    NeuroPace
    Operator Number
    10044401
    Address
    455 N. Bernardo Avenue
    City
    Mountain View
    State
    CA
    Postal Code
    94043
    Country
    US
    Correspondent
    Cindy Heintzelman

    Products

    Device Name Product Code
    Implanted Brain Stimulator For Epilepsy PFN
    Cover, Burr Hole GXR

    Proprietary Names

    NeuroPace RNS System RNS System NeuroPace Burr Hole Cover

    Establishment Types

    Manufacture Medical Device