BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EPITEL

    Reg #: 3014692331 · FEI: 3014692331 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

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    Registration Details

    Registration Name
    EPITEL
    Registration Number
    3014692331
    FEI Number
    3014692331
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    465 South 400 East, Suite 250
    City
    Salt Lake City
    State
    UT
    ZIP
    84111
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231779

    Owner / Operator

    Firm Name
    Epitel
    Operator Number
    10082545
    Address
    465 S 400 E, Suite 250
    City
    Salt Lake City
    State
    UT
    Postal Code
    84111
    Country
    US

    Products

    Device Name Product Code
    Automatic Event Detection Software For Full-Montage Electroencephalograph OMB
    Reduced- Montage Standard Electroencephalograph OMC
    Electrode, Cutaneous GXY

    Proprietary Names

    REMI

    Establishment Types

    Manufacture Medical Device