BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Long Extension IMRIS 1.5T

    Reg #: 3028006458 · FEI: 3028006458 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ClearPoint Neuro Inc.
    Registration Number
    3028006458
    FEI Number
    3028006458
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6349 Paseo Del Lago
    City
    Carlsbad
    State
    CA
    ZIP
    92011
    Country
    US

    Regulatory Submissions

    510(k) Number
    K090267

    Owner / Operator

    Firm Name
    ClearPoint Neuro, Inc.
    Operator Number
    9038590
    Address
    120 S Sierra Ave
    City
    Solana Beach
    State
    CA
    Postal Code
    92075
    Country
    US
    Correspondent
    Megan Faulkenberry

    Products

    Device Name Product Code
    Coil, Magnetic Resonance, Specialty MOS

    Proprietary Names

    Long Extension IMRIS 1.5T

    Establishment Types

    Manufacture Medical Device