Device Classification Name |
automatic event detection software for full-montage electroencephalograph
|
510(k) Number |
K211452 |
Device Name |
Encevis |
Applicant |
Austrian Institute of Technology GmbH |
Giefinggasse 4 |
Vienna,
AT
1210
|
|
Applicant Contact |
Tilmann Kluge |
Correspondent |
Austrian Institute of Technology GmbH |
Giefinggasse 4 |
Vienna,
AT
1210
|
|
Correspondent Contact |
Tilmann Kluge |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/10/2021 |
Decision Date | 12/02/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|