BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Spirometer, Resting, Stress ECG systems

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

    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
    K082478

    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
    Spirometer, Diagnostic BZG

    Proprietary Names

    Spirometer, Resting, Stress ECG systems Electrocardiographs Devices - Cardioperfect Workstand (software and hardware) multiple & accessories

    Establishment Types

    Manufacture Medical Device