DEVICE: eego amplifier (B195EE511)
Device Identifier (DI) Information
eego amplifier
EE-511
In Commercial Distribution
eemagine Medical Imaging Solutions GmbH
EE-511
In Commercial Distribution
eemagine Medical Imaging Solutions GmbH
physiological signal amplfier
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
36740 | Electroencephalographic signal amplifier |
An electrical device intended to amplify the signal level and to provide impedance matching between two or more medical devices when bioelectrical signals from the brain are transmitted between them.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GWL | AMPLIFIER, PHYSIOLOGICAL SIGNAL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K172312 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
43c336b8-56db-4243-8835-fe7cd563ec3c
November 28, 2022
2
April 29, 2022
November 28, 2022
2
April 29, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+493029048404
support@eemagine.com
support@eemagine.com