Device Classification Name |
stimulator, nerve, battery-powered
|
510(k) Number |
K091155 |
Device Name |
ASCEND |
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 | 868.2775
|
Classification Product Code |
|
Date Received | 04/21/2009 |
Decision Date | 09/03/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|