Device Classification Name |
Full-Montage Standard Electroencephalograph
|
510(k) Number |
K904269 |
Device Name |
NEUROSEARCH-24 OR NRS-24 |
Applicant |
LEXICOR MEDICAL TECHNOLOGY, INC. |
2585 CENTRAL AVE. |
BOULDER,
CO
80301
|
|
Applicant Contact |
MICHAEL HICKEY |
Correspondent |
LEXICOR MEDICAL TECHNOLOGY, INC. |
2585 CENTRAL AVE. |
BOULDER,
CO
80301
|
|
Correspondent Contact |
MICHAEL HICKEY |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/18/1990 |
Decision Date | 06/04/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|