BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    patient cables and leadwires

    Reg #: 9611295 · FEI: 3002807992 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SPACELABS HEALTHCARE LTD.
    Registration Number
    9611295
    FEI Number
    3002807992
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit B, Foxholes Centre, JOHN TATE ROAD
    City
    HERTFORD Hertfordshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K011837

    Owner / Operator

    Firm Name
    SPACELABS HEALTHCARE, INC.
    Operator Number
    2022906
    Address
    35301 SE CENTER STREET, --
    City
    Snoqualmie
    State
    WA
    Postal Code
    98065
    Country
    US

    Products

    Device Name Product Code
    Electrocardiograph, Ambulatory (Without Analysis) MWJ

    Proprietary Names

    patient cables and leadwires Holter Kits EVO Recorder Lifecard CF (LCF) 50-0018, 50-0034, 50-0035, 50-0044, 50-0045, 50-0169 LCF3LCH, LCF3LGER, LCF3LUK, LCFKIT, LCF4L LC12, LC12CH, LC12GER, LC12KIT, LC12KITUS, LC12US

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility