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    FDA Registration Active 🇨🇦 Canada

    NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)

    Reg #: 9612330 · FEI: 3002809369 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    48
    Establishment Types
    3
    Classifications
    20

    Registration Details

    Registration Name
    NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
    Registration Number
    9612330
    FEI Number
    3002809369
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2568 BRISTOL CIR.
    City
    OAKVILLE Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K090277

    Owner / Operator

    Firm Name
    Natus Medical Incorporated
    Operator Number
    9004873
    Address
    3150 Pleasant View Road
    City
    Middleton
    State
    WI
    Postal Code
    53562
    Country
    US

    US Agent

    Business Name
    Natus
    Contact Name
    Courtney Walton
    Address
    3610 County Road 101 S
    City
    Wayzata
    State
    MN
    ZIP
    55391
    Country
    US
    Email
    [email protected]
    Phone
    651 4215870

    Products

    Device Name Product Code
    Automatic Event Detection Software For Polysomnograph With Electroencephalograph OLZ
    Amplitude-Integrated Electroencephalograph OMA
    Reduced- Montage Standard Electroencephalograph OMC
    Electrode, Cutaneous GXY
    Automatic Event Detection Software For Full-Montage Electroencephalograph OMB
    Support, Patient Position CCX
    Cable, Electrode IKD
    Full-Montage Standard Electroencephalograph GWQ
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Electrode, Cortical GYC
    Standard Polysomnograph With Electroencephalograph OLV
    Ventilatory Effort Recorder MNR
    Monitor, Breathing Frequency BZQ
    Electromyograph, Diagnostic IKN
    Burst Suppression Detection Software For Electroencephalograph ORT
    Stimulator, Auditory, Evoked Response GWJ
    Stimulator, Photic, Evoked Response GWE
    Stimulator, Electrical, Evoked Response GWF
    System, Image Processing, Radiological LLZ
    Source Localization Software For Electroencephalograph Or Magnetoencephalograph OLX

    Proprietary Names

    Sleepworks software CFM Olympic Brainz Monitor Snap Electrode Xltek EEG Spike and Event Detector Olympic Vac-Pac Microelectrode recording cable MER Cable Holder for Dantec™ DCN Disposable Concentric Needle Electrodes Cable Electrodes EEG32 EEG32U PK1188 10399 Excel Neuro Works Neuroworks Natus Neuroworks Quantum Embla NDx EMbla Dx Natus Brain Monitor Embla SDx XactTrace Universal XactTrace Belts Breath Sensors Excel EMG ICTA, ICTA-S, ICTA-D MPR Sleep Monitor Embletta MPR Background Pattern Classification Brain Monitor with Neonatal Sensor EMU 40 NeurWorks Natus NeuroWorks Xltek Brain Monitor Xltek Connex Trex HD Video Trex HD Neuroworks Software Trex HD Monitoring Protektor32 Photic Stimulator XactTrace® Single Use Respiratory Effort Belt System Natus Photic Stimulator 128 Channel EEG Headbox EMU128S OBM-Recognize Olympic Brain Monitor XLTEK LED goggles EMU40EX Brainwatch with headbnd GRIDVIEW SOFTWARE

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility