EEG NeuroAmp II

GUDID 04251341900047

Option Temperature Sensor pIRx3

CORSCIENCE GmbH & Co. KG

Biofeedback system
Primary Device ID04251341900047
NIH Device Record Key948d6953-a62d-40a5-a657-ff86ffc3565a
Commercial Distribution StatusIn Commercial Distribution
Brand NameEEG NeuroAmp II
Version Model NumberCS10289
Company DUNS333427776
Company NameCORSCIENCE GmbH & Co. KG
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 Datefalse
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
GS104251341900047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HCCDevice, Biofeedback

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-05-22

On-Brand Devices [EEG NeuroAmp II]

04251341900047Option Temperature Sensor pIRx3
04251341900023CS10137-02
04251341900016CS10137

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