EB NEURO SPA

Address:VIA PIETRO FANFANI 97/A,FLORENCE Tuscany,IT

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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

Stimulator, Electrical, Evoked Response (GWF) (9) Electromyograph, Diagnostic (IKN) (2) Non-Normalizing Quantitative Electroencephalograph Software (OLT) (1) Standard Polysomnograph With Electroencephalograph (OLV) (1) Stimulator, Auditory, Evoked Response (GWJ) (1) Device, Nerve Conduction Velocity Measurement (JXE) (1) Stimulator, Photic, Evoked Response (GWE) (1) Full-Montage Standard Electroencephalograph (GWQ) (1)

Premarket Exempt

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STM9000 ULTRA-FAST - 08056446900550 Catalog Number :

Device Description : Magnetic neural stimulation equipment. (Power supply voltage: 115VAC).

Device Class : 2

Duns Number: 339182263

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

STM9000 ULTRA-FAST_BI - 08056446900567 Catalog Number :

Device Description : Magnetic neural stimulation equipment. (Power supply voltage: 115VAC).

Device Class : 2

Duns Number: 339182263

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Circular Coil 90 mm - 08056446900581 Catalog Number :

Device Description : Magnetic stimulation coil

Device Class : 2

Duns Number: 339182263

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Circular Coil 70 mm - 08056446900598 Catalog Number :

Device Description : Magnetic stimulation coil

Device Class : 2

Duns Number: 339182263

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Butterfly Coil 70 mm - 08056446900604 Catalog Number :

Device Description : Magnetic stimulation coil

Device Class : 2

Duns Number: 339182263

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Butterfly Coil 70 mm air cooled - 08056446900611 Catalog Number :

Device Description : Magnetic stimulation coil

Device Class : 2

Duns Number: 339182263

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Butterfly Coil 80 mm, 120° - 08056446900628 Catalog Number :

Device Description : Magnetic stimulation coil

Device Class : 2

Duns Number: 339182263

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Circular Coil 90 mm air cooled - 08056446900635 Catalog Number :

Device Description : Magnetic stimulation coil

Device Class : 2

Duns Number: 339182263

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Galileo NT Line Software - 08056446900642 Catalog Number :

Device Description : Software for EEG, EMG, EP and other applications based on acquiring, processing Software for EEG, EMG, EP and other applications based on acquiring, processing and analyzing of biological electrical signals. Identifier (8012) contains the software version.

Device Class : 2

Duns Number: 339182263

Premarket Exempt : No

Product Code : JXE, OLV, GWJ, GWE, GWF, IKN, GWQ, OLT

Prescription Use : Yes

Device Count : 1

Isolation Transformer ‘GP’ 110-120 VAC 50/60 Hz - 08056446900659 Catalog Number :

Device Description : Isolation Transformer for EEG/EMG/EP systems

Device Class : 2

Duns Number: 339182263

Premarket Exempt : No

Product Code : IKN

Prescription Use : Yes

Device Count : 1

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