BEUDAMED
    FDA Registration Active 🇺🇸 United States

    H-Scribe 5 Holter Analysis system

    Reg #: 1316463 · FEI: 1316463 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    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
    K004017

    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
    Electrocardiograph, Ambulatory, With Analysis Algorithm MLO

    Proprietary Names

    H-Scribe 5 Holter Analysis system Hscribe Holter Analysis System H-Scribe Holter Analysis System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility