BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AC/DC Powered Ophthalmoscope - 117 Series Ophthalmoscope, 118 Series Ophthalmoscope and accessories

    Reg #: 1316463 · FEI: 1316463 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    WELCH ALLYN, INC.
    Registration Number
    1316463
    FEI Number
    1316463
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4341 STATE STREET RD.
    City
    Skaneateles Falls
    State
    NY
    ZIP
    13153
    Country
    US

    Regulatory Submissions

    510(k) Number
    K003376

    Owner / Operator

    Firm Name
    BAXTER HEALTHCARE CORPORATION
    Operator Number
    1417572
    Address
    One Baxter Parkway
    City
    Deerfield
    State
    IL
    Postal Code
    60015
    Country
    US
    Correspondent
    Maha Nolasco

    Products

    Device Name Product Code
    Ophthalmoscope, Ac-Powered HLI
    Ophthalmoscope, Battery-Powered HLJ

    Proprietary Names

    AC/DC Powered Ophthalmoscope - 117 Series Ophthalmoscope, 118 Series Ophthalmoscope and accessories Diagnostic Sets w/PanOptic Plus Accessory Desk Sets w/PanOptic Plus GS777 Integrated Wall Systems w/117 LED Ophthalmoscope Diagnostic Set w/117 LED Ophthalmoscope Enhanced Diagnostic Sets w/PanOptic Plus Welch Allyn PanOptic Basic Oph US Premium Diagnostic Sets w/PanOptic Plus Standard Diagnostic Set w/Ophthalmoscope Welch Allyn PanOptic Plus Oph US PanOptic Basic & Plus Eye Cup (set of 5) GS777 Integrated Wall Systems w/LED Ophthalmoscope GS777 Integrated Wall Systems w/PanOptic Plus Ophthalmoscope

    Establishment Types

    Manufacture Medical Device