FDA.reportPublic FDA data

BE Micro 21 CH MONO PLUG-IN HEADBOX

Primary DI
08056446900949
Brand
BE Micro 21 CH MONO PLUG-IN HEADBOX
Company
EB NEURO SPA
Model
B8830073310
Device description
Patient-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
GWLAmplifier, Physiological Signal
GWQFull-Montage Standard Electroencephalograph
MNRVentilatory Effort Recorder
OLVStandard Polysomnograph With Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWLAmplifier, Physiological SignalNeurology2
GWQFull-Montage Standard ElectroencephalographNeurology2
MNRVentilatory Effort RecorderAnesthesiology2
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
08056446900949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056446900949080564469009498056446900949

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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08056446901106NExT-DOCKINGB97000960002025-05-22
08056446901113NExT-PADB97000960102025-05-22
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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
08056446900895BE PLUS PRO LIGHTB97000780012024-12-04

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