Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006125362

FEI Number

3006125362

Entity Name

NEUROVIRTUAL USA, INC.

City/State/Country

Fort Lauderdale, FL, US

Establishment Address

3303 W Commercial Blvd, Suite 100, Fort Lauderdale, FL 33309, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NEUROVIRTUAL USA, INC. (Owner Number: 9091724)

Owner / Operator Contact Address

3303 W Commercial Blvd, Suite 100, Fort Lauderdale, FL 33309, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201495

PMA Number

N/A

All Registered Proprietary Names

Neurovirtual BWIII Basics Neurovirtual BWIII EEG Plus Sleepvirtual BWIII PSG Plus Sleepvirtual BWIII PSG Neurovirtual BWIII EEG Maxxi Rip System 3ft Maxxi Rip Pediatric Belt Maxxi Rip System 7ft Maxxi Rip ABD Interface Maxxi Rip Small Belt Maxxi Rip XXLarge Belt Maxxi Rip XLarge Belt Maxxi Rip Adjustable Belt Maxxi Rip Large Belt Maxxi Rip Infant Belt Maxxi Rip THX Interface Maxxi Gold Cup Electrode Maxxi Gold Cutaneous Surface Electrode Maxxi Position Sensor Maxxi Cannula BWMINI PSG BWMINI EEG BWMINI HST BWMINI COMPASS HST BWMINI BASICS Maxxi Flow Sensor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2011-11-08
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2011-11-08
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2019-10-25
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2017-04-12
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2020-04-27
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2020-04-27
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2020-09-04
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2015-04-24
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2015-04-24
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2020-12-14
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2020-12-14

Official Correspondent

EDUARDO FARIA

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NEUROVIRTUAL USA, INC.

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
K082968	Apneicare, LLC	APNEICARE CONNECTION CENTER/INTERNET ANALYSIS	2009-01-02
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

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.

Similar Registrations

Registration Number	Establishment Name	Location
3005733633	EPM GLOBAL SERVICES INC., DBA VEXOS	Markham Ontario, CA
3007389703	NOX MEDICAL	Reykjavik, IS
3016852448	Nihon Kohden Corporation - Eastern Japan Logistics Center	Sakado City Saitama, JP
2080783	NIHON KOHDEN AMERICA, INC.	Irvine, CA, US
3026753386	ONERA B.V.	Eindhoven Noord-Brabant, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006125362. Last updated year: 2026. Please use registration number 3006125362 when referencing this establishment in official correspondence.