BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GE Brightspeed Elite

    Reg #: 3005810333 · FEI: 3005810333 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BAY SHORE MEDICAL EQUIPMENT, LLC
    Registration Number
    3005810333
    FEI Number
    3005810333
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    61 Deer Lane
    City
    Manorville
    State
    NY
    ZIP
    11949
    Country
    US

    Regulatory Submissions

    510(k) Number
    K082816

    Owner / Operator

    Firm Name
    Bay Shore Medical Equipment, LLC
    Operator Number
    10037139
    Address
    61 Deer Lane
    City
    Manorville
    State
    NY
    Postal Code
    11949
    Country
    US
    Correspondent
    John Kollegger

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    GE Brightspeed Elite BrightSpeed Excel Select GE Brightspeed Elite Select BrightSpeed Edge Select Brightspeed 16

    Establishment Types

    Repack or Relabel Medical Device