Device Classification Name |
stimulator, nerve, battery-powered
|
510(k) Number |
K110118 |
Device Name |
STIMTRODE SINGLE USE NERVE STIMULATOR |
Applicant |
XAVANT TECHNOLOGY (PTY), LTD. |
169 GARSFONTEIN ROAD |
ASHLEA GARDENS |
PRETORIA, GAUTENG,
ZA
0081
|
|
Applicant Contact |
BRIAN ROTHMAN |
Correspondent |
XAVANT TECHNOLOGY (PTY), LTD. |
169 GARSFONTEIN ROAD |
ASHLEA GARDENS |
PRETORIA, GAUTENG,
ZA
0081
|
|
Correspondent Contact |
BRIAN ROTHMAN |
Regulation Number | 868.2775
|
Classification Product Code |
|
Date Received | 01/18/2011 |
Decision Date | 02/17/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|