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GUDID B195ES820

aEEG monitoring

eemagine Medical Imaging Solutions GmbH

Electroencephalographic monitoring system, stationary
Primary Device IDB195ES820
NIH Device Record Keycb61c350-a701-4052-b460-15c513f83d6b
Commercial Distribution StatusIn Commercial Distribution
Brand Nameneo
Version Model NumberES-820
Company DUNS313152485
Company Nameeemagine Medical Imaging Solutions GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Customer Support Contacts

Phone+493029048404
Emailsupport@eemagine.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB195ES820 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OMAAmplitude-integrated electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-05
Device Publish Date2020-02-26

On-Brand Devices [neo]

B195LE800aEEG monitoring
B195ES820aEEG monitoring

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