FDA.reportPublic FDA data

BE Micro USB BRIDGE

Primary DI
08056446900024
Brand
BE Micro USB BRIDGE
Company
EB NEURO SPA
Model
B8830073000
Device description
USB interface for EEG ambulatory recorder
Published
2019-04-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter
GWLAmplifier, Physiological Signal
GWQFull-Montage Standard Electroencephalograph
OLVStandard Polysomnograph With Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
GWLAmplifier, Physiological SignalNeurology2
GWQFull-Montage Standard ElectroencephalographNeurology2
OLVStandard Polysomnograph With ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093728000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093728000BE MICRO, TREAEb Neuro S.P.A.2010-04-29OLV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056446900024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056446900024080564469000248056446900024

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic ambulatory recorderAn electrically-powered device designed for 24-hour recording of electroencephalographic signals in ambulatory patients for periods usually from 24 to 72 hours to assess a variety of neurological conditions (e.g., epilepsy) and psychiatric disorders. It typically includes a small cassette tape recorder or a digital medium (no moving parts) with appropriate signal amplifiers worn by the patient, and a set of scalp electrodes that are placed on the cranium of the patient. The resulting electroencephalogram (EEG) is typically analysed in an electroencephalographic analyser.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+390554565111info@ebneuro.com

Regulatory Flags#

DUNS number
339182263
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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08056446901137NExT-HSB97001080002025-05-22
08056446901168NExT-AMPB96300960022025-05-22
08056446901199NExT-ASB91090001412025-05-22
08056446901205NExT StationB98000960012025-05-22
08056446901090NExT Station AdvancedB98000960002025-05-19
08056446900642Galileo NT Line SoftwareB86400530002020-05-25
08056446900659Isolation Transformer ‘GP’ 110-120 VAC 50/60 HzB97000410012019-05-24
08056446900178Flash Led StimulatorB97000630002019-04-10
08056446900185USB FLASH ADAPTER CABLE L=3mB91006308002024-12-04
08056446900192USB FLASH ADAPTER CABLE L=5mB91006308102024-12-04
08056446900673Neurotravel LIGHTB98001020002024-12-04
08056446900680Neurotravel LIGHT Base UnitB97001020002024-12-04
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