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510(k) Data Aggregation
K Number
K201495Device Name
Maxxi Flow Sensor
Manufacturer
Date Cleared
2020-12-14
(192 days)
Product Code
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
Neurovirtual USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Maxxi Flow sensor is a respiratory sensor. It is placed under the patient's and produce a signal that is directly proportional to the temperature changes of air inhaled and exhaled during respiration. Maxxi Flow sensors generate a small analog electrical signal that provides a clear, reliable indication of respiration airflow. This sensor is intended to be used with polysomnography devices and adult patients.
Intended to be use in a sleep laboratory, clinics or hospitals.
Device Description
MAXXI FLOW SENSOR Thermocouple based sensors detect change of breath temperature between ambient temperature (inhalation) and lung temperature (exhalation). A thermocouple placed in front of a nostril detects breathing as a temperature change.
The product is offered in 2 different length sizes, 3ft and 7ft.
Maxxi Flow sensor is compatible with Neurovirtual PSG devices.
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K Number
K191492Device Name
Maxxi Position Sensor
Manufacturer
Date Cleared
2020-04-24
(324 days)
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
Neurovirtual USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Maxxi Position Sensor is intended for use with the BWMini polysomnograph system, to acquire the body position of adult patients during sleep studies. The Sensor produces signals for five positions: supine, prone, left and right. It is intended for use in research, home sleep studies, ambulatory, and clinical environments.
Device Description
The Maxxi Position Sensor is a sensor that attaches to either around chest or abdominal belts using velcro tapes- so no additional belts or attachment systems are needed. The sensor features a fully encapsulated active element for troublefree cleaning. The Maxxi Position Sensor produces a clear and reliable signal for five positions: Upright, supine, prone, left and right. It comes with 7ft long cable for a convenient connection with the PSG device recorder.
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K Number
K191095Device Name
Maxxi Snore Sensor
Manufacturer
Date Cleared
2020-01-16
(266 days)
Product Code
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
Neurovirtual USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Maxxi Snore Sensor is a device intended to acquire snore bursts. It responds to snoring and other sounds in the audio range picked up through the skin and convert them to a small analog voltage that provides an indication of the presence of these sound/vibration bursts. This sensor is intended to be used with polysomnography devices and adult patients. Intended to be use in a sleep laboratory, clinics or hospitals.
Device Description
MAXXI SNORE SENSOR piezo electric based sensors detect sound and vibration of the snore through skin contact. The sensor is placed on the patient neck surface where it can easily detect the snoring bursts during the sleep study. The product is offered in 2 different length sizes, 3ft and 7ft. The sensor is compatible with any recording device with the DIN 42-802 receptacle which is the gold standard for PSG recording machines.
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K Number
K171304Device Name
Maxxi Rip Sensor
Manufacturer
Date Cleared
2019-06-24
(782 days)
Product Code
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
Neurovirtual USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Maxxi RIP Sensor is intended for measuring of respiratory effort signals. They function as accessories for sleep/ polysomnography (PSG) systems.
The device is offered in different sizes to be used on adult patients.
The intended environments are hospitals, institutions, sleep centers or sleep clinics.
Device Description
Maxxi Rip Sensor is a device intended to capture respiratory effort from a patient and output the signal to a PSG device for sleep studies. This signal is captured using an elastic belt fastened around the thorax or abdomen that will exhibit a change in tension as the thorax or abdomen expands or contracts. This change in tension is measured and converted to a signal output by the interface and processed by a PSG device.
The product is composed of 3 major parts, the interface box, the cable and the belt.
Cables are used to connect between the respiratory effort sensor (RIP belts) and the applicable sleep recorder/polysomnography (PSG) system.
The device is offered in different sizes to be used on adult patients.
The Maxxi Rip was validated with Neurovirtual BWMini PSG device recorder only, therefore we don't quarantee compatibility with other devices.
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K Number
K163547Device Name
MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96
Manufacturer
Date Cleared
2017-04-11
(116 days)
Product Code
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
NEUROVIRTUAL USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MaxxiGold Electrode is intended for non-invasive use as recording electrodes in studies of physiological signals. These devices are indicated for use with adult or pediatric patients during electroencephalography, including biofeedback, sleep studies and evoked potential recordings.
Device Description
MAXXI GOLD Electrode is intended for non-invasive use as recording electrodes in studies of physiological signals. These devices are indicated for use with adult or pediatric patients during electroencephalography, including biofeedback, sleep studies and evoked potential recordings.
The product is offered in 3 different lenath sizes, 48", 60" or 96". The product is offered in package of 5 or 10 units, with multicolor wires.
The electrode is compatible with any recording device with the DIN 42-802 receptacle which is the gold standard for EEG and EMG recording machines.
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K Number
K131335Device Name
BWMINI EEG, BWMINIHST, BWMINI PSG
Manufacturer
Date Cleared
2015-02-03
(635 days)
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
NEUROVIRTUAL USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BWMini is an electroencephalograph, which is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.
BWMini is multi-channel (up to 32 channels) system designed for Electroencephalograph (EEG), Polysomnography (PSG) and Home Sleep Testing (HST) recording application, in research, home sleep studies, ambulatory and clinical environments.
The BWMini does not make any judgment of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.
Device Description
BWMini is an electroencephalograph, which is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.
BWMini is multi-channel (up to 32 channels) system designed for Electroencephalograph (EEG), Polysomnography (PSG) and Home Sleep Testing (HST) recording application, in research, home sleep studies, ambulatory and clinical environments.
The BWMini does not make any judgment of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.
The device is software based (Windows), uses a memory card for data storage, has a hard plastic external material, and is powered by batteries. It has up to 32 channels, 16 Bits AD Resolution, 50-60Hz Notch Filter, 1-500uv/mm Configurable Sensitivity Selection, 0.16 - 15Hz Configurable Low Frequency filters, 15 - 100 Hz Configurable High Frequency filters, and 2 DC Inputs. The user interface is IBM PC.
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K Number
K112107Device Name
BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS
Manufacturer
Date Cleared
2011-10-28
(98 days)
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
NEUROVIRTUAL USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BWIII system may be used for electroencephalography (EEG) and sleep recordings (Polysomnography) in research and clinical environments. It acquires displays and archives EEG and PSG data for on-screen review, annotation, and event-marking by the user.
The BWIII requires competent user input, and its output must be reviewed and interpreted by a trained physician who will exercise professional judgment in using this information.
The BWIII does not make any judgment of normality or abnormality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.
Device Description
BWIII is multi-channel (up to 50 channels) system designed for polysomnography (PSG) and electroencephalograph (EEG) recording application, in sleep lab, hospital or clinical environment under the supervision of a physician, using a laptop or a desktop computer.
The BWIII system consists of four major components: the amplifier unit, head box unit, flash stimulator unit and the power module (all plastic made). The system provides connections for electrodes and sensors, and connects to the computer using an ethernet cable.
The BWIII works with any good quality patient leads / electrodes and sensors snore, flow, effort belts and position) that have the safety touch connectors and are legally marketed in accordance with FDA requirements. As these accessories are already legally in the market from different manufactures, they are not part of this submission.
The BWIII does not make any judgment of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.
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K Number
K062533Device Name
BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524
Manufacturer
Date Cleared
2006-12-22
(115 days)
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
NEUROVIRTUAL USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BWII system may be used for electroencephalography (EEG) and sleep recordings (polysomnography) in research and dinical environments. It acquires, displays, and archives EEG and PSG data for on screen review, annotation and event marking by the user. The BWII system also allows for computer-assisted, usercontrolled quantitative analysis of EEG.
The BWII system is not intended to replace conventional devices or methods used for EEG and PSG monitoring in critical care or intraoperative settings.
The BWII system requires competent user input, and its output must be reviewed and interpreted by a trained technicians or neurologists who will exercise professional judgment in using this information.
The BWII system does not make any judgment of normality or abnormality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.
Device Description
BWII is multi-channel (up to 25 channels) system designed for electroencephalograph (EEG) and polysomnography (PSG) recording application, in sleep lab, hospital or dinical environment under the supervision of a physician, using a lap top or a desk top computer.
The BWII system consists of three maior components: the Amplifier Unit, the Power Module (Both plastic made) and the BWAnalysis Software (a CD to be installed on a regular PC). The system provides connections for electrodes and sensors, and connects to the computer using an Ethernet cable.
The BWII works with any good quality patient leads / electrodes and sensors (snore, flow, effort belts and position) that have the safety touch connectors and are legally marketed in accordance with FDA requirements. As these accessories are already legally on the market from different manufactures, they are not part of this submission.
The BWII does not make any judgment of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.
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