FDA.reportPublic FDA data

eego amplifier

Primary DI
B195EE411
Brand
eego amplifier
Company
eemagine Medical Imaging Solutions GmbH
Model
EE-411
Device description
physiological signal amplfier
Published
2018-05-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWLAMPLIFIER, PHYSIOLOGICAL SIGNAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWLAmplifier, Physiological SignalNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172312000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172312000eego amplifiersEemagine Medical Imaging Solutions GmbH2018-03-30GWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B195EE411PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic signal amplifierAn electrical device that amplifies the signal level and provides impedance matching between two or more medical devices when bioelectrical signals from the brain are transmitted between them. It could typically be used when using an electroencephalograph (EEG).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+493029048404support@eemagine.com

Regulatory Flags#

DUNS number
313152485
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B195XC813waveguardXC-8132026-03-19
B195CA520waveguardCA-5202025-12-16
B195CA521waveguardCA-5212025-12-16
B195CA522waveguardCA-5222025-12-16
B195NA215waveguardNA-2152025-12-16
B195NA276waveguardNA-2762025-12-16
B195NA415waveguardNA-4152025-12-16
B195XC315waveguardXC-3152025-12-16
B195XS268waveguardXS-2682025-12-16
B195XS269waveguardXS-2692025-12-16
B195XS272waveguardXS-2722025-12-16
B195XS297waveguardXS-2972025-12-16
B195EE223eego amplifierEE-2232025-09-29
B195EE225eego amplifierEE-2252025-09-29
B195LC100cognitraceLC-1002021-07-27
B195LC104cognitraceLC-1042020-04-30
B195LC105cognitraceLC-1052020-04-30
B195LC106cognitraceLC-1062020-04-30
B195LC107cognitraceLC-1072020-04-30
B195SC100cognitraceSC-1002020-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009903715Quick-20mCGX, LLCGWL2025-09-29
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B195EE225eego amplifiereemagine Medical Imaging Solutions GmbHGWL2025-09-29
00817111021332PolysmithNeurotronics, LLCGWL2025-09-23
08056446900338NeMus 2 600EB NEURO SPAGWL2025-05-26
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08056446900901BE PLUS PRO STANDARDEB NEURO SPAGWL2024-12-04
08056446900918BE PLUS PRO FULLEB NEURO SPAGWL2024-12-04
08056446900925BE PLUS PRO ADVANCEDEB NEURO SPAGWL2024-12-04
08056446900932BE PLUS PRO Battery PackEB NEURO SPAGWL2024-12-04
08056446901311BE PLUS PRO [LIGHT] EB NEURO SPAGWL2024-12-04
08056446901328BE PLUS PRO [STANDARD]EB NEURO SPAGWL2024-12-04
08056446901335BE PLUS PRO [FULL]EB NEURO SPAGWL2024-12-04
08056446901342BE PLUS PRO [ADVANCED]EB NEURO SPAGWL2024-12-04
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