EB NEURO SPA

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

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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

Amplifier, Physiological Signal (GWL) (9) Full-Montage Standard Electroencephalograph (GWQ) (5) Standard Polysomnograph With Electroencephalograph (OLV) (5) Oximeter (DQA) (3) Ventilatory Effort Recorder (MNR) (3)

Premarket Exempt

Clear

BE Micro - 08056446900000 Catalog Number :

Device Description : EEG Long Term-Abulatory System

Device Class : 2

Duns Number: 339182263

Premarket Exempt : No

Product Code : DQA, GWQ, GWL, OLV, MNR

Prescription Use : Yes

Device Count : 1

BE Micro Recorder - 08056446900017 Catalog Number :

Device Description : EEG Long Term-Abulatory Recorder

Device Class : 2

Duns Number: 339182263

Premarket Exempt : No

Product Code : GWQ, GWL, OLV, MNR

Prescription Use : Yes

Device Count : 1

BE Micro USB BRIDGE - 08056446900024 Catalog Number :

Device Description : USB interface for EEG ambulatory recorder

Device Class : 2

Duns Number: 339182263

Premarket Exempt : No

Product Code : DQA, OLV, GWL, GWQ

Prescription Use : Yes

Device Count : 1

BE Micro Saturimeter - 08056446900031 Catalog Number :

Device Description : Pulse oximeter for EEG ambulatory recorder

Device Class : 2

Duns Number: 339182263

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

BE Micro PLUG-IN HEADBOX - 08056446900048 Catalog Number :

Device Description : Patient-interface for EEG ambulatory recorder

Device Class : 2

Duns Number: 339182263

Premarket Exempt : No

Product Code : GWQ, GWL, OLV

Prescription Use : Yes

Device Count : 1

BE Micro Headbox - 08056446900055 Catalog Number :

Device Description : Patient-interface for EEG ambulatory recorder

Device Class : 2

Duns Number: 339182263

Premarket Exempt : No

Product Code : MNR, GWQ, GWL, OLV

Prescription Use : Yes

Device Count : 1

BE PLUS LTM - 08056446900079 Catalog Number :

Device Description : EEG Amplifier with accessories

Device Class : 2

Duns Number: 339182263

Premarket Exempt : No

Product Code : GWL

Prescription Use : Yes

Device Count : 1

BE PLUS LTM - 08056446900086 Catalog Number :

Device Description : EEG Amplifier

Device Class : 2

Duns Number: 339182263

Premarket Exempt : No

Product Code : GWL

Prescription Use : Yes

Device Count : 1

BE PLUS LTM PLUG-IN HEADBOX, 32-CHANNELS - 08056446900093 Catalog Number :

Device Description : 32 channels patient-interface for EEG amplifier

Device Class : 2

Duns Number: 339182263

Premarket Exempt : No

Product Code : GWL

Prescription Use : Yes

Device Count : 1

BE PLUS LTM PLUG-IN HEADBOX, 64-CHANNELS - 08056446900109 Catalog Number :

Device Description : 64 channels patient-interface for EEG amplifier

Device Class : 2

Duns Number: 339182263

Premarket Exempt : No

Product Code : GWL

Prescription Use : Yes

Device Count : 1

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