Device Classification Name |
non-normalizing quantitative electroencephalograph software
|
510(k) Number |
K143487 |
Device Name |
Lifelines iEEG |
Applicant |
KVIKNA EHF |
STORHOFOI 21 |
REYKJAVIK,
IS
110
|
|
Applicant Contact |
Gardar Thorvardsson |
Correspondent |
Smith Assoicates |
1468 Harwell Avenue |
Crofton,
MD
21114
|
|
Correspondent Contact |
Yolanda Smith |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/08/2014 |
Decision Date | 08/21/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|