BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Espion

    Reg #: 1221363 · FEI: 1221363 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    DIAGNOSYS LLC
    Registration Number
    1221363
    FEI Number
    1221363
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    55 TECHNOLOGY DR STE 100
    City
    Lowell
    State
    MA
    ZIP
    01851
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221471

    Owner / Operator

    Firm Name
    DIAGNOSYS LLC
    Operator Number
    1221363
    Address
    55 Technology Drive, Suite 100
    City
    Lowell
    State
    MA
    Postal Code
    01851
    Country
    US
    Correspondent
    Jeff D Farmer

    Products

    Device Name Product Code
    Stimulator, Photic, Evoked Response GWE
    Preamplifier, Ac-Powered, Ophthalmic HLT

    Proprietary Names

    Espion ColorFlash stimulator ColorBurst stimulator E3 S2 controller ColorDome stimulator LCD monitor Envoy monitor Profile

    Establishment Types

    Manufacture Medical Device