Device Classification Name |
reduced- montage standard electroencephalograph
|
510(k) Number |
K192549 |
Device Name |
Byteflies Kit |
Applicant |
Byteflies NV |
Borsbeeksebrug 22 Floor 6 |
Antwerp,
BE
B-2600
|
|
Applicant Contact |
Benjamin Vandendriessche |
Correspondent |
MedicSense USA |
Borsbeeksebrug 22, 6th Floor |
Berchem |
Antwerpen,
BE
2600
|
|
Correspondent Contact |
Benjamin Vandendriessche |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 09/17/2019 |
Decision Date | 06/22/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|