BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RadiAnalyzer Xpress Monitor Cable 12900 Series

    Reg #: 3005334138 · FEI: 3005334138 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    St. Jude Medical, Cardiology Division, Inc.
    Registration Number
    3005334138
    FEI Number
    3005334138
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    5050 Nathan Lane North
    City
    Plymouth
    State
    MN
    ZIP
    55442
    Country
    US

    Regulatory Submissions

    510(k) Number
    K172182

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    Computer, Blood-Pressure DSK
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    RadiAnalyzer Xpress Monitor Cable 12900 Series RadiAnalyzer Adapter Cables 12600 series Quantien Measurement System C12787 Quantien Measurement System AUX OUT Cable C12796 Quantien Measurement System Quantien Measurement System AUX IN Cable C12500-C12510 Quantien Mounting Stands and Brackets Quantien Measurement System Adapter C12600 series RadiAnalyzer Xpress Cable Converter C12784 Quantien Measurement System Monitor Cables C12900 Series

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198