Device Classification Name |
recorder, attention task performance
|
510(k) Number |
K143468 |
Device Name |
QbCheck |
Applicant |
QBTECH AB |
Kungsgatan 29 |
stockholm,
SE
11156
|
|
Applicant Contact |
hans bostrom |
Correspondent |
QBTECH AB |
Kungsgatan 29 |
stockholm,
SE
11156
|
|
Correspondent Contact |
hans bostrom |
Classification Product Code |
|
Date Received | 12/04/2014 |
Decision Date | 03/22/2016 |
Decision |
substantially equivalent
(SESE) |
510k Review Panel |
Neurology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|