Device Classification Name |
device, nerve conduction velocity measurement
|
510(k) Number |
K041320 |
Device Name |
MODIFICATION TO NC-STAT |
Applicant |
NEUROMETRIX, INC. |
62 FOURTH AVE. |
WALTHAM,
MA
02451
|
|
Applicant Contact |
JOSEPH F BURKE |
Correspondent |
NEUROMETRIX, INC. |
62 FOURTH AVE. |
WALTHAM,
MA
02451
|
|
Correspondent Contact |
JOSEPH F BURKE |
Regulation Number | 882.1550
|
Classification Product Code |
|
Date Received | 05/18/2004 |
Decision Date | 08/12/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|