Device Classification Name |
Electrode, Cutaneous
|
510(k) Number |
K121816 |
Device Name |
SENSUS ELECTRODE |
Applicant |
NEUROMETRIX, INC. |
62 FOURTH AVE. |
WALTHAM,
MA
02451
|
|
Applicant Contact |
RAINER MAAS |
Correspondent |
NEUROMETRIX, INC. |
62 FOURTH AVE. |
WALTHAM,
MA
02451
|
|
Correspondent Contact |
RAINER MAAS |
Regulation Number | 882.1320
|
Classification Product Code |
|
Date Received | 06/20/2012 |
Decision Date | 11/26/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|