Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010611950

FEI Number

3010611950

Entity Name

Natus Neurology Incorporated

City/State/Country

Middleton, WI, US

Establishment Address

3150 Pleasant View Road, Middleton, WI 53562, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,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

Expiration Date (Year)

2026

510(k) Number

K021185

PMA Number

N/A

All Registered Proprietary Names

OBM-Recognize Olympic Brain Monitor CFM Olympic Brainz Monitor NICOLET EDX Component Neuromonitoring System NICOLETONE SYSTEM V32 AMPLIFIER ALGO Pro Newborn Hearing Screening Device IMEXDOP CT+ Synergy EP/EMG System Synergy NICOLET CORTICAL STIMULATOR NICOLET VERSALAB ELECTROENCEPHALOGRAPH EEG ELECTRODE/SURFACE TWISTED PAIR DG NERVUS NICOLET EDX 8-04-12700, 1073 ICS Chartr EP 200 Insert 2 Ch, US Only 8-04-12720, 1073 ICS Chartr EP 200 Insert, Bone & TDH49 2Ch, DS only 8-04-12702, 1073 ICS Chartr EP 200 Insert, Bone 2 Ch, US only 8-04-12703, 1073 ICS Chartr EP 200 Insert, Bone & TDH49 2Ch, US only Trex HD Trex HD Monitoring NICOLET WIRELESS EEG CAREDOP II CAM02 Camino ICP Monitor CAMCABL Camino Fiber Optic Catheter Cable 026950 14.4V Li-ion Battery 025420 PMIO Patient Bedside Monitor Cable 025440 USB-to-RS232 Adapter Cable 025430 AC Power Adapter Background Pattern Classification POCKET DOP 3 VikingQuest Brainwatch with headbnd 8-04-15101, 1082 AURICAL HIT STERILE EMG ELECTRODES Natus Photic Stimulator UltraPro S100 with Integrated Ultrasound NicoletOne Nicolet EDX with Integrated Ultrasound Quantum NERVUS MONITOR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OMA	Amplitude-Integrated Electroencephalograph	Neurology	Class 2	882.1400	2013-07-03
OMB	Automatic Event Detection Software For Full-Montage Electroencephalograph	Neurology	Class 2	882.1400	2013-07-03
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2013-07-03
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
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2012-12-12
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2012-12-12
GZP	Stimulator, Mechanical, Evoked Response	Neurology	Class 2	882.1880	2012-12-12
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2012-12-12
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2012-12-12
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2012-12-12
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2012-12-12
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2023-08-09
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2023-08-09
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2023-08-09
OMA	Amplitude-Integrated Electroencephalograph	Neurology	Class 2	882.1400	2023-08-09
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2023-08-09
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2023-08-09
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2012-12-13
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2024-03-21
JAF	Monitor, Ultrasonic, Nonfetal	Radiology	Class 2	892.1540	2012-12-13
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2013-01-18
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2013-01-18
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2013-01-18
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2013-01-18
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2013-01-18
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2012-12-13
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2012-12-13
JOP	Transducer, Ultrasonic	Cardiovascular	Class 2	870.2880	2012-12-13
JAF	Monitor, Ultrasonic, Nonfetal	Radiology	Class 2	892.1540	2012-12-13
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2012-12-13
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2012-12-13
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2012-12-13
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2012-12-13
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2012-12-13
GZP	Stimulator, Mechanical, Evoked Response	Neurology	Class 2	882.1880	2012-12-13
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2012-12-13
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2012-12-13
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2012-12-13
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2012-12-13
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2019-11-08
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
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2012-12-13
GWL	Amplifier, Physiological Signal	Neurology	Class 2	882.1835	2012-12-13
JAF	Monitor, Ultrasonic, Nonfetal	Radiology	Class 2	892.1540	2012-12-12
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2018-01-26
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
HEP	Monitor, Blood-Flow, Ultrasonic	Obstetrics/Gynecology	Class 2	884.2660	2012-12-13
GZP	Stimulator, Mechanical, Evoked Response	Neurology	Class 2	882.1880	2017-12-27
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2017-12-27
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2017-12-27
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2017-12-27
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2017-12-27
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2017-12-27
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2017-12-27
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2024-12-06
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2024-12-06
ETW	Calibrator, Hearing Aid / Earphone And Analysis Systems	Ear, Nose, Throat	Class 2	874.3310	2019-11-08
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2012-12-13
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2012-12-13
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2018-06-19
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2025-01-24
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2025-01-24
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2025-01-24
GZP	Stimulator, Mechanical, Evoked Response	Neurology	Class 2	882.1880	2025-01-24
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2025-01-24
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2025-01-24
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2025-01-24
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2018-11-20
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2018-11-20
OMB	Automatic Event Detection Software For Full-Montage Electroencephalograph	Neurology	Class 2	882.1400	2018-11-20
OLZ	Automatic Event Detection Software For Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2018-11-20
OMA	Amplitude-Integrated Electroencephalograph	Neurology	Class 2	882.1400	2018-11-20
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2025-01-24
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2025-01-24
GZP	Stimulator, Mechanical, Evoked Response	Neurology	Class 2	882.1880	2025-01-24
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2025-01-24
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2025-01-24
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2025-01-24
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2025-01-24
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
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2012-12-13
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2012-12-13

Official Correspondent

Sanjay Mehta

US Agent Details

No US Agent registered (Local establishment).

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
9612330	NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)	OAKVILLE Ontario, CA
2023988	Natus Medical Incorporated	SAN DIEGO, CA, US
3005581270	Natus Manufacturing Limited	GORT, Co. Galway, IE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033010	Brainz Instruments , Ltd.	BRM2 BRAIN MONITOR	2003-10-10
K991012	Siemens Medical Solutions USA, Inc.	SIEMENS INFINITY EEG POD	1999-06-24
K852587	Tracor Northern, Inc.	CDSA(COLOR DENSITY, SPECTRAL ARRRAY)	1985-08-16
K880088	Cadwell Laboratories, Inc.	CADWELL EXCEL	1988-05-04
K201432	Masimo Corporation	Masimo O3 Regional Oximeter System	2020-08-29

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-0020-2025	Philips North America Llc	2	IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Z-1027-2026	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
Z-1321-2023	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supplies are related to the following Tempus Pro Patient Monitoring units: Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R
Z-1666-2025	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010611950. Last updated year: 2026. Please use registration number 3010611950 when referencing this establishment in official correspondence.