BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MAC 5 Lite Resting ECG Analysis System

    Reg #: 3012359877 · FEI: 3012359877 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    GE Medical Systems Information Technologies, Inc.
    Registration Number
    3012359877
    FEI Number
    3012359877
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9900 Innovation Drive
    City
    Wauwatosa
    State
    WI
    ZIP
    53226
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221321

    Owner / Operator

    Firm Name
    GE HealthCare Technologies Inc.
    Operator Number
    9912004
    Address
    3000 N. Grandview Blvd
    City
    Waukesha
    State
    WI
    Postal Code
    53188
    Country
    US

    Products

    Device Name Product Code
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Computer, Diagnostic, Programmable DQK
    Electrocardiograph DPS

    Proprietary Names

    MAC 5 Lite Resting ECG Analysis System MAC 5 A4 MAC 5 Lite MAC 5 A5 Resting ECG Analysis System MAC 5 A5 MAC 5 A4 Resting ECG Analysis System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility