Natus Neurology Incorporated

Registration Details

Registration Name: Natus Neurology Incorporated
Registration Number: 3010611950
FEI Number: 3010611950
Status: Active
Expiry Year: 2026
Initial Importer: Yes
Address: 3150 Pleasant View Road
City: Middleton
State: WI
ZIP: 53562
Country: US

Regulatory Submissions

510(k) Number: K120979

Owner / Operator

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

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Amplitude-Integrated Electroencephalograph	OMA	Class 2	Neurology	No	2013-07-03
Automatic Event Detection Software For Full-Montage Electroencephalograph	OMB	Class 2	Neurology	No	2013-07-03
Reduced- Montage Standard Electroencephalograph	OMC	Class 2	Neurology	No	2013-07-03
Non-Normalizing Quantitative Electroencephalograph Software	OLT	Class 2	Neurology	No	2012-12-12
Stimulator, Electrical, Evoked Response	GWF	Class 2	Neurology	No	2012-12-12
Stimulator, Mechanical, Evoked Response	GZP	Class 2	Neurology	No	2012-12-12
Device, Nerve Conduction Velocity Measurement	JXE	Class 2	Neurology	No	2012-12-12
Electromyograph, Diagnostic	IKN	Class 2	Physical Medicine	No	2012-12-12
Stimulator, Auditory, Evoked Response	GWJ	Class 2	Neurology	No	2012-12-12
Stimulator, Photic, Evoked Response	GWE	Class 2	Neurology	No	2012-12-12
Oximeter, Tissue Saturation	MUD	Class 2	Cardiovascular	No	2023-08-09
Full-Montage Standard Electroencephalograph	GWQ	Class 2	Neurology	No	2023-08-09
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	Class 2	Cardiovascular	No	2023-08-09
Burst Suppression Detection Software For Electroencephalograph	ORT	Class 2	Neurology	No	2023-08-09
Monitor, Ultrasonic, Nonfetal	JAF	Class 2	Radiology	No	2012-12-13
Electrode, Cortical	GYC	Class 2	Neurology	No	2012-12-13
Stimulator, Nerve	ETN	Class 2	Ear, Nose, Throat	No	2012-12-13
Transducer, Ultrasonic	JOP	Class 2	Cardiovascular	No	2012-12-13
Electrode, Cutaneous	GXY	Class 2	Neurology	No	2012-12-13
Standard Polysomnograph With Electroencephalograph	OLV	Class 2	Neurology	No	2016-11-10
Amplifier, Physiological Signal	GWL	Class 2	Neurology	No	2012-12-13
Device, Monitoring, Intracranial Pressure	GWM	Class 2	Neurology	No	2018-01-26
Monitor, Blood-Flow, Ultrasonic	HEP	Class 2	Obstetrics/Gynecology	No	2012-12-13
Calibrator, Hearing Aid / Earphone And Analysis Systems	ETW	Class 2	Ear, Nose, Throat	No	2019-11-08
Electrode, Needle	GXZ	Class 2	Neurology	No	2012-12-13
Electrode, Needle, Diagnostic Electromyograph	IKT	Class 2	Physical Medicine	No	2012-12-13
Automatic Event Detection Software For Polysomnograph With Electroencephalograph	OLZ	Class 2	Neurology	No	2018-11-20
Methyl Methacrylate For Cranioplasty	GXP	Class 2	Neurology	No	2013-06-07
Monitor, Ultrasonic, Fetal	KNG	Class 2	Obstetrics/Gynecology	No	2013-01-18
Cable, Electrode	IKD	Class 2	Physical Medicine	No	2015-01-19
System, Monitoring, Perinatal	HGM	Class 2	Obstetrics/Gynecology	No	2012-12-13
Unit, Neonatal Phototherapy	LBI	Class 2	General Hospital	No	2018-12-13

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 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 Synergy Focus Natus Synergy Focus UltraPro S100 IMEXDOP IR FreeDop Embla NDx EMbla Dx Natus Brain Monitor Embla SDx Microelectrode recording cable MER Cable Holder for Dantec DCN Disposable Concentric Needle Electrodes Cable Electrodes VERSALAB APM CNS Envision EMU40EX neoBLUE blanket LED Phototherapy System PocketDop II

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device