NEUROVIRTUAL USA, INC.

Address:3303 W Commercial Blvd,Fort Lauderdale,FL,33309,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Standard Polysomnograph With Electroencephalograph (OLV) (5) Ventilatory Effort Recorder (MNR) (3) Full-Montage Standard Electroencephalograph (GWQ) (2) Device, Sleep Assessment (LEL) (1)

Premarket Exempt

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Neurovirtual - 00850008393204 Catalog Number : PV2008

Device Description : Polysomnograph BWIII PSG

Device Class : 2

Duns Number: 791140622

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Neurovirtual - 00850008393211 Catalog Number : PV2009

Device Description : Polysomnograph and Electroencephalograph BWIII PSG Plus

Device Class : 2

Duns Number: 791140622

Premarket Exempt : No

Product Code : GWQ, OLV

Prescription Use : Yes

Device Count : 1

Neurovirtual - 00850008393228 Catalog Number : PV2311

Device Description : Polysomnograph BWMini PSG

Device Class : 2

Duns Number: 791140622

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Neurovirtual - 00850008393235 Catalog Number : PV2310

Device Description : Electroencephalograph BWMini EEG

Device Class : 2

Duns Number: 791140622

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Neurovirtual - 00850008393242 Catalog Number : PV2312

Device Description : Polysomnograph BWMini HST

Device Class : 2

Duns Number: 791140622

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Neurovirtual - 00850008393259 Catalog Number : SI1842

Device Description : Polysomnograph BWMini HST Compass

Device Class : 2

Duns Number: 791140622

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Neurovirtual - 00850008393266 Catalog Number : SI1866

Device Description : piezo-electric element covered by Thermoplastic elastomers 2 ft lenght

Device Class : 2

Duns Number: 791140622

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Neurovirtual - 00850008393273 Catalog Number : SI1784

Device Description : The Maxxi Snore Sensor is a device intended to acquire snore bursts

Device Class : 2

Duns Number: 791140622

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Neurovirtual - 00850008393280 Catalog Number : SI1487

Device Description : The Maxxi Snore Sensor is a device intended to acquire snore bursts

Device Class : 2

Duns Number: 791140622

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Neurovirtual - 00850008393297 Catalog Number : SI

Device Description : The Maxxi Position Sensor is intended for use with the polysomnograph system to The Maxxi Position Sensor is intended for use with the polysomnograph system to acquire the body position of adult patients during sleep studies

Device Class : 2

Duns Number: 791140622

Premarket Exempt : No

Product Code : LEL

Prescription Use : Yes

Device Count : 1

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