Device Classification Name |
recorder, attention task performance
|
510(k) Number |
K141865 |
Device Name |
DANA |
Applicant |
ANTHROTRONIX, INC |
8737 COLESVILLE ROAD |
SUITE L-203 |
SILVER SPRING,
MD
20910
|
|
Applicant Contact |
CORINA E LATHAN, PHD, PE |
Correspondent |
ANTHROTRONIX, INC |
8737 COLESVILLE ROAD |
SUITE L-203 |
SILVER SPRING,
MD
20910
|
|
Correspondent Contact |
CORINA E LATHAN, PHD, PE |
Classification Product Code |
|
Date Received | 07/10/2014 |
Decision Date | 10/15/2014 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|