BE Micro

GUDID 08056446900000

EEG Long Term-Abulatory System

EB NEURO SPA

Electroencephalographic ambulatory recorder
Primary Device ID08056446900000
NIH Device Record Key52393435-08c6-4081-8309-c78fad485100
Commercial Distribution StatusIn Commercial Distribution
Brand NameBE Micro
Version Model NumberB9800073000
Company DUNS339182263
Company NameEB NEURO SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108056446900000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2019-04-01

Devices Manufactured by EB NEURO SPA

08056446900642 - Galileo NT Line Software2020-06-02 Software for EEG, EMG, EP and other applications based on acquiring, processing and analyzing of biological electrical signals.
08056446900154 - Battery Charger2020-02-06 Battery Charger for Battery Pack
08056446900017 - BE Micro Recorder2019-11-08 EEG Long Term-Abulatory Recorder
08056446900024 - BE Micro USB BRIDGE2019-11-08 USB interface for EEG ambulatory recorder
08056446900048 - BE Micro PLUG-IN HEADBOX2019-11-08 Patient-interface for EEG ambulatory recorder
08056446900055 - BE Micro Headbox2019-11-08 Patient-interface for EEG ambulatory recorder
08056446900949 - BE Micro 21 CH MONO PLUG-IN HEADBOX2019-11-08 Patient-interface for EEG ambulatory recorder
08056446900956 - BE Micro PLUG-IN HEADBOX 19 CH MONO+2CH BIPOL2019-11-08 Patient-interface for EEG ambulatory recorder

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.