Device Classification Name |
Non-Normalizing Quantitative Electroencephalograph Software
|
510(k) Number |
K191322 |
Device Name |
E-EEGX, N-EEGX |
Applicant |
GE Healthcare Finland Oy |
Kuortaneenkatu 2 |
Helsinki,
FI
FI-00510
|
|
Applicant Contact |
Joel Kent |
Correspondent |
GE Healthcare Finland Oy |
Kuortaneenkatu 2 |
Helsinki,
FI
FI-00510
|
|
Correspondent Contact |
Joel Kent |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/15/2019 |
Decision Date | 01/22/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|