BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    SPACELABS HEALTHCARE LTD.

    Reg #: 9611295 · FEI: 3002807992 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    52
    Establishment Types
    1
    Classifications
    10

    Registration Details

    Registration Name
    SPACELABS HEALTHCARE LTD.
    Registration Number
    9611295
    FEI Number
    3002807992
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Unit B, Foxholes Centre, JOHN TATE ROAD
    City
    HERTFORD Hertfordshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K003251

    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
    Gas-Machine, Anesthesia BSZ
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Electrocardiograph, Ambulatory (Without Analysis) MWJ
    Computer, Diagnostic, Programmable DQK
    Electrode, Electrocardiograph DRX
    Electrocardiograph DPS
    Ventilator, Continuous, Facility Use CBK
    Vaporizer, Anesthesia, Non-Heated CAD
    Ventilatory Effort Recorder MNR
    Transmitters And Receivers, Electrocardiograph, Telephone DXH

    Proprietary Names

    Blease Focus Model 90217A Model 90207 Eclipse PRO Eclipse PRO cable P/N 700-0372-00 700-0373-00 700-3878-00 700-0374-00 700-0375-00 700-0376-00 700-0379-00 700-0377-00 Eclipse PRO cable P/N 700-0372-01 700-0373-01 700-3878-01 700-0374-01 700-0375-01 700-0376-01 700-0379-01 700-0377-01 015-0724-00 Micro-V Alternans Sensor (MV4), Case of 5 pouches 040-1747-00 PC, Configured, HearTwave II, 90200 700-0336-01 Patient Cable, Standard Stress, PM-3, US 015-0722-00 Micro-V Alternans Sensor (MV4), Case of 20 pouches 700-0332-01 Micro-V Cable US 700-0338-01 Patient Cable, Standard Stress, PM-3, EU 700-0334-01 Micro-V Cable EU 015-0721-00 Micro-V Alternans Sensor (MV4), Pouch of 7 685-0260-00 PM-3 Patient Module 700-0356-01 EP Junction Cable US 015-0725-00 Micro-V Alternans Sensor (MV4), Case of 1 pouch Eclipse Mini ECG Sensor Eclipse Pro ECG Sensor CardioDirect airway flow sensors Arkon SL3, SL6, and SL12 98900 Eclipse Mini and Assoc. Supplies & Accessories Eclipse MINI patient cables and leadwires Holter Kits Lifecard CF (LCF) EVO Recorder LCF3LCH, LCF3LGER, LCF3LUK, LCFKIT, LCF4L 50-0018, 50-0034, 50-0035, 50-0044, 50-0045, 50-0169 LC12, LC12CH, LC12GER, LC12KIT, LC12KITUS, LC12US Model 90227 OnTrak Ambulatory Blood Pressure Cuffs Cuff Covers Datum Pathfinder SL Holter Analyzer BleaseGenius Models 950, 970, & 990 900 Series Ventilator Sentinel Sentinel V10.x Model 98200 Model 98201 Sentinel V11.x Lifescreen Pro Model 98800 CARDIOCALL EVENT RECORDER Patient cables & leadwires Holter kits BleaseSirius

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility