Device Classification Name |
automatic event detection software for full-montage electroencephalograph
|
510(k) Number |
K132306 |
Device Name |
PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE |
Applicant |
PERSYST DEVELOPMENT CORP. |
12625 HIGH BLUFF DRIVE |
SUITE 213 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
DARI DARABBEIGI |
Correspondent |
PERSYST DEVELOPMENT CORP. |
12625 HIGH BLUFF DRIVE |
SUITE 213 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
DARI DARABBEIGI |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/24/2013 |
Decision Date | 11/21/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|