Device Classification Name |
Automatic Event Detection Software For Full-Montage Electroencephalograph
|
510(k) Number |
K950117 |
Device Name |
PERSYST SPIKE DETECTOR |
Applicant |
PERSYST CONSULTING SERVICES, INC. |
605 E ST. |
BELMAR,
NJ
07719
|
|
Applicant Contact |
SCOTT B WILSON |
Correspondent |
PERSYST CONSULTING SERVICES, INC. |
605 E ST. |
BELMAR,
NJ
07719
|
|
Correspondent Contact |
SCOTT B WILSON |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 01/11/1995 |
Decision Date | 04/05/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|