BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    015-0724-00 Micro-V Alternans Sensor (MV4), Case of 5 pouches

    Reg #: 9611295 · FEI: 3002807992 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    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
    K050225

    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
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    015-0724-00 Micro-V Alternans Sensor (MV4), Case of 5 pouches 040-1747-00 PC, Configured, HearTwave II, 90200 685-0260-00 PM-3 Patient Module 700-0334-01 Micro-V Cable EU 015-0721-00 Micro-V Alternans Sensor (MV4), Pouch of 7 700-0338-01 Patient Cable, Standard Stress, PM-3, EU 700-0356-01 EP Junction Cable US 015-0722-00 Micro-V Alternans Sensor (MV4), Case of 20 pouches 700-0336-01 Patient Cable, Standard Stress, PM-3, US 700-0332-01 Micro-V Cable US 015-0725-00 Micro-V Alternans Sensor (MV4), Case of 1 pouch

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility