Device Classification Name |
Automatic Event Detection Software For Full-Montage Electroencephalograph
|
510(k) Number |
K133793 |
Device Name |
PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE |
Applicant |
PERSYST DEVELOPMENT CORPORATION |
12625 HIGH BLUFF DRIVE, SUITE 213 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
DARI DARABBEIGI |
Correspondent |
PERSYST DEVELOPMENT CORPORATION |
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 | 12/13/2013 |
Decision Date | 05/19/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|