BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Spacelabs Healthcare Inc.

    Reg #: 3010157426 · FEI: 3010157426 · Expires 2026
    View on FDA
    Products
    34
    Proprietary Names
    120
    Establishment Types
    4
    Classifications
    34

    Registration Details

    Registration Name
    Spacelabs Healthcare Inc.
    Registration Number
    3010157426
    FEI Number
    3010157426
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    35301 SE Center St
    City
    Snoqualmie
    State
    WA
    ZIP
    98065
    Country
    US

    Regulatory Submissions

    510(k) Number
    K063490

    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
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Detector And Alarm, Arrhythmia DSI
    System, Network And Communication, Physiological Monitors MSX
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Monitor, St Segment With Alarm MLD
    Infusor, Pressure, For I.V. Bags KZD
    Electrocardiograph DPS
    Index-Generating Electroencephalograph Software OLW
    Burst Suppression Detection Software For Electroencephalograph ORT
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Reduced- Montage Standard Electroencephalograph OMC
    Antimicrobial Blood Pressure Cuff OED
    Electrocardiograph, Ambulatory (Without Analysis) MWJ
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Blood Pressure Cuff DXQ
    Oximeter DQA
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Gas-Machine, Anesthesia BSZ
    Recorder, Paper Chart DSF
    Ventilator, Continuous, Facility Use CBK
    Ventilatory Effort Recorder MNR
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Continuous Measurement Thermometer FLL
    Computer, Blood-Pressure DSK
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Full-Montage Standard Electroencephalograph GWQ
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR

    Proprietary Names

    Model 91810 - Full Disclosure Capnography Module Model 92517 Xhibit Model 96102 XC4 Model 96501 21.5 inch display, P/N 011-0241-02 21.5 inch display, P/N 011-0262-00 Model 91220 Unifusor pressure infusors CardioDirect BISx module Model 91482 EEG Patient Cables and Leadwires EEG Patient Cable Adapters Ultracheck Curve blood pressure cuffs blood pressure hoses blood pressure accessories 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 Sentinel Sentinel V10.x Model 98200 Model 98201 Sentinel V11.x Ultracheck blood pressure cuffs Model 96181 Smart Alarm Interface Models 90436A-15, 90436A-16, 90437A-05, 90439, 90442A-02, 90442-03 Models 91439A-A, 91439B, 91439B-A, 91443A-A, 91443B-A Models 90436A-01, 90436A-07, 90436A-09, 90436A-10-32, 90436A-10B, 90436A-10E Models 90519B-A, 91436A-A, 91436B-A, 91436C-A, 91436D-A, 91436E-A, 91438A-A Model 90227 OnTrak Ambulatory Blood Pressure Cuffs Cuff Covers Aria-Tele Model 96281 Models 90343, 90347, 91343, 91347 Models 90478 & 90479 Enhanced Telemetry Receiver Model 96280 Blease Focus Models 91881 & 92881 Models 90449, 90469, & 91449 Softcheck blood pressure cuffs Ultracheck Spacelabs ABP cuffs Model 92516 Capnography Pod BleaseSirius Pathfinder SL Holter Analyzer ECG electrodes blood pressure cuffs & hoses elance Central Station Monitor Model 93300 patient adapter cables ECG leadwires & cables Model 93900 elance Vital Signs Monitor Models 91847 and 92847 part number 14000018 700 series ventilators blood pressure cuffs and hoses UltraView SL Command Module Model 90496 Command Module Model 91496 Pulse oximetry cables and sensors Patient adapter cables Models 91393 and 94267 Single Care Cuffs BleaseGenius Model 92810 - Smart Disclosure CARDIOCALL EVENT RECORDER Patient cables & leadwires Holter kits Peraserver Peratrend 98900 Eclipse Mini and Assoc. Supplies & Accessories Eclipse MINI Models 90341 & 91341 Models 90491, 90499, & 91493 Model 91390 Model 91389 Qube Mini Monitor Qube Docking Station - 016-0922-00 Qube Compact Monitor Models 950, 970, & 990 900 Series Ventilator 90516 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 90360 remote control Models 91367, 91369, 91370, 91387, & 91388 Model 91424 PCMS SvO2 module Perawatch Peramobile Lifescreen Pro Model 98800 airway flow sensors Arkon Model 90481 various EEG cables and leadwires airway adapters gas sample lines Model 92518 Ultraview SL Capnograph Module cannulas Model 91517 Model 90217A Model 90207 Model 91518 water traps

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Device in the United States for Export Only