Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006418479

FEI Number

3006418479

Entity Name

NEUROSOFT LTD

City/State/Country

Ivanovo Ivanovskaya Oblast', RU

Establishment Address

5 Voronin Street, Ivanovo Ivanovskaya Oblast' 153032, RU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Neurosoft LTD (Owner Number: 10035792)

Owner / Operator Contact Address

5 Voronin Street, Ivanovo, RU-IVA 153032, RU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K130878

PMA Number

N/A

All Registered Proprietary Names

Focus Neuro-MEP-Micro Neuron-Spectrum-3 with Neuron-Spectrum.NET software Neuron-Spectrum-2 with Neuron-Spectrum.NET software Neuron-Spectrum-4 with Neuron-Spectrum.NET software Neuron-Spectrum-4/P with Neuron-Spectrum.NET software Neuron-Spectrum-1 with Neuron-Spectrum.NET software NoetherTech MEGA-TMS Neuro-MS CloudTMS Edge for OCD Neuro-MSX Steadys-Step gait analysis and gait training system Neuron-Spectrum-AM with Neuron-Spectrum.NET Software aTymp Neurosoft TMS CloudTMS Cloud TMS Focus TMS FocusTMS Neuro-MS/D Neuro-IOM system with Neuro-IOM.NET software, models - 32/B - 32/S - 16/S Neuro-IOM Rivus NEURO-AUDIO CloudEKG Poly-Spectrum-8/EX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2011-03-24
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2011-03-24
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2015-06-25
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2015-06-25
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2015-06-25
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2021-08-20
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2021-08-20
QCI	Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder	Neurology	Class 2	882.5802	2023-12-25
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2023-08-11
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2022-12-16
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2022-12-16
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2022-12-16
PTP	Tympanometer, Exempt	Ear, Nose, Throat	Class 2	874.1090	2023-01-27
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2017-07-19
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2021-05-28
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2021-05-28
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2021-05-28
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2021-05-28
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2021-05-28
EXY	Uroflowmeter	Gastroenterology, Urology	Class 2	876.1800	2023-01-27
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2017-07-19
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2017-07-19
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2017-07-19

Official Correspondent

Mikhail Durdin

US Agent Details

Joe F Jabre Business: TeleEMG, LLC Email: jjabre@teleemg.com Phone: (617) 8403253

Related Public Records

Same Entity

Neurosoft LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K161650	Neurotronics, Inc.	Polysmith Sleep System, Model NTI7593	2017-01-19
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

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.

Similar Registrations

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8030229	NIHON KOHDEN TOMIOKA PRODUCTION CENTER	TOMIOKA-SHI Gunma, JP
3005581270	Natus Manufacturing Limited	GORT, Co. Galway, IE
3010611950	Natus Neurology Incorporated	Middleton, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006418479. Last updated year: 2026. Please use registration number 3006418479 when referencing this establishment in official correspondence.