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

FDA Device Registration & Listing · OAKVILLE Ontario, CA · Registration 9612330

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9612330
FEI Number
3002809369
Entity Name
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
City/State/Country
OAKVILLE Ontario, CA
Establishment Address
2568 BRISTOL CIR., OAKVILLE Ontario L6H 5S1, CA
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Natus Medical Incorporated (Owner Number: 9004873)
Owner / Operator Contact Address
3150 Pleasant View Road, Middleton, WI 53562, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K173793
PMA Number
N/A

All Registered 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 Trex HD Monitoring Protektor32 Photic Stimulator XactTrace® Single Use Respiratory Effort Belt System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph Neurology Class 2 882.1400 2011-05-05
OMA Amplitude-Integrated Electroencephalograph Neurology Class 2 882.1400 2010-06-21
OMC Reduced- Montage Standard Electroencephalograph Neurology Class 2 882.1400 2010-06-21
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2017-11-13
OMB Automatic Event Detection Software For Full-Montage Electroencephalograph Neurology Class 2 882.1400 2008-10-23
CCX Support, Patient Position Anesthesiology Class 1 868.6820 2009-06-19
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2015-01-19
GWQ Full-Montage Standard Electroencephalograph Neurology Class 2 882.1400 2008-02-06
OMA Amplitude-Integrated Electroencephalograph Neurology Class 2 882.1400 2018-03-19
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2018-03-19
OMB Automatic Event Detection Software For Full-Montage Electroencephalograph Neurology Class 2 882.1400 2018-03-19
GYC Electrode, Cortical Neurology Class 2 882.1310 2018-03-06
GWQ Full-Montage Standard Electroencephalograph Neurology Class 2 882.1400 2018-03-06
OLV Standard Polysomnograph With Electroencephalograph Neurology Class 2 882.1400 2018-03-06
GWQ Full-Montage Standard Electroencephalograph Neurology Class 2 882.1400 2018-06-19
OLV Standard Polysomnograph With Electroencephalograph Neurology Class 2 882.1400 2018-06-19
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2012-12-11
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2019-10-08
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2019-10-08
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2008-02-06
OMB Automatic Event Detection Software For Full-Montage Electroencephalograph Neurology Class 2 882.1400 2012-07-23
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2013-07-22
ORT Burst Suppression Detection Software For Electroencephalograph Neurology Class 2 882.1400 2016-06-06
OMA Amplitude-Integrated Electroencephalograph Neurology Class 2 882.1400 2016-06-06
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2010-06-21
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2010-06-21
OMC Reduced- Montage Standard Electroencephalograph Neurology Class 2 882.1400 2010-06-21
GWQ Full-Montage Standard Electroencephalograph Neurology Class 2 882.1400 2008-02-06
OMA Amplitude-Integrated Electroencephalograph Neurology Class 2 882.1400 2020-05-19
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2020-05-19
OMB Automatic Event Detection Software For Full-Montage Electroencephalograph Neurology Class 2 882.1400 2020-05-19
OLV Standard Polysomnograph With Electroencephalograph Neurology Class 2 882.1400 2007-12-19
OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph Neurology Class 2 882.1400 2007-12-19
OMB Automatic Event Detection Software For Full-Montage Electroencephalograph Neurology Class 2 882.1400 2007-12-19
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2007-12-19
OLV Standard Polysomnograph With Electroencephalograph Neurology Class 2 882.1400 2014-03-21
GWQ Full-Montage Standard Electroencephalograph Neurology Class 2 882.1400 2014-03-21
OMB Automatic Event Detection Software For Full-Montage Electroencephalograph Neurology Class 2 882.1400 2010-03-15
OMA Amplitude-Integrated Electroencephalograph Neurology Class 2 882.1400 2010-03-15
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2010-03-15
GWQ Full-Montage Standard Electroencephalograph Neurology Class 2 882.1400 2016-11-10
OLV Standard Polysomnograph With Electroencephalograph Neurology Class 2 882.1400 2016-11-10
GWJ Stimulator, Auditory, Evoked Response Neurology Class 2 882.1900 2010-08-16
GWE Stimulator, Photic, Evoked Response Neurology Class 2 882.1890 2010-08-16
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2010-08-16
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2010-08-16
GWE Stimulator, Photic, Evoked Response Neurology Class 2 882.1890 2008-02-06
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2019-03-12

Official Correspondent

No official correspondent registered.

US Agent Details

Courtney Walton Business: Natus Email: Courtney.Walton@Natus.com Phone: (651) 4215870

Related Public Records

Same Entity

Natus Medical Incorporated
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
2023988 Natus Medical Incorporated SAN DIEGO, CA, US
3010611950 Natus Neurology Incorporated Middleton, WI, US
3005581270 Natus Manufacturing Limited GORT, Co. Galway, IE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K070612 Top-Rank Health Care Equipment Co., Ltd. TOP-RANK ADHESIVE ELECTRODE 2007-05-07
K123915 Grass Technologies, an Astro-Med, Inc. Product Gro DE48-PLUS 2013-04-24
K073532 Technomed Europe DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES 2008-05-01
K260363 Ceribell, Inc. Ceribell Brain Monitor Headband 2026-04-03
K091762 Covidien DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE 2009-12-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2008 Bio-Logic Systems Corp 2
Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.
Z-0031-2022 NOX MEDICAL Keldnaholt Reykjavik Iceland 2
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612330. Last updated year: 2026. Please use registration number 9612330 when referencing this establishment in official correspondence.
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