Device Classification Name |
Amplitude-Integrated Electroencephalograph
|
510(k) Number |
K081551 |
Device Name |
TWIN NEUROTRAC-III |
Applicant |
ASTRO-MED, INC. |
600 EAST GREENWICH AVE. |
WEST WARWICK,
RI
02893
|
|
Applicant Contact |
ALFREDO BUSTAMANTE |
Correspondent |
ASTRO-MED, INC. |
600 EAST GREENWICH AVE. |
WEST WARWICK,
RI
02893
|
|
Correspondent Contact |
ALFREDO BUSTAMANTE |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/03/2008 |
Decision Date | 12/24/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|