Device Classification Name |
Normalizing Quantitative Electroencephalograph Software
|
510(k) Number |
K974748 |
Device Name |
NEUROMETRIC ANALYSIS SYSTEM |
Applicant |
NXLINK, LTD. |
1706 GAILLARD PL. |
RICHLAND,
WA
99352 -2624
|
|
Applicant Contact |
DUANE SHUTTLESWORTH |
Correspondent |
NXLINK, LTD. |
1706 GAILLARD PL. |
RICHLAND,
WA
99352 -2624
|
|
Correspondent Contact |
DUANE SHUTTLESWORTH |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 12/19/1997 |
Decision Date | 07/10/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|