Device Classification Name |
non-normalizing quantitative electroencephalograph software
|
510(k) Number |
K001324 |
Device Name |
SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS) |
Applicant |
NEURO SCAN LABS |
5700 CROMO DR., SUITE 100 |
EL PASO,
TX
79912 -5538
|
|
Applicant Contact |
DAVID B JONES |
Correspondent |
NEURO SCAN LABS |
5700 CROMO DR., SUITE 100 |
EL PASO,
TX
79912 -5538
|
|
Correspondent Contact |
DAVID B JONES |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/26/2000 |
Decision Date | 07/11/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|