| Device Classification Name |
stimulator, nerve, battery-powered
|
| 510(K) Number |
K121743 |
| Device Name |
EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN |
| Applicant |
| SUNMED LLC |
| c/o easymed instruments co,5/ -6/f,block a,gupo gongmao bldg |
| fengxin rd, fengxiang industrial district |
|
daliang, shunde, foshan,
|
|
| Contact |
wu tingjie |
| Regulation Number | 868.2775
|
| Classification Product Code |
|
| Date Received | 06/13/2012 |
| Decision Date | 03/28/2013 |
| Decision |
substantially equivalent (SE) |
| Classification Advisory Committee |
Anesthesiology
|
| Review Advisory Committee |
Anesthesiology
|
| summary |
summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Expedited Review |
No
|
| Combination Product |
No
|
|
|