Device Classification Name |
Stimulator, Nerve, Battery-Powered
|
510(k) Number |
K140853 |
Device Name |
STIMPOD ST2-3010 NERVE STIMULATOR |
Applicant |
XAVANT TECHNOLOGY (PTY) LTD |
Ravello 1st Floor, Delmondo Office Park |
169 GARSFONTEIN ROAD ASHLEA GARDENS |
PRETORIA, GAUTENG,
ZA
0081
|
|
Applicant Contact |
Roche van Rensburg |
Correspondent |
XAVANT TECHNOLOGY (PTY) LTD |
Ravello 1st Floor, Delmondo Office Park |
169 GARSFONTEIN ROAD ASHLEA GARDENS |
PRETORIA, GAUTENG,
ZA
0081
|
|
Correspondent Contact |
Roche van Rensburg |
Regulation Number | 868.2775
|
Classification Product Code |
|
Date Received | 04/03/2014 |
Decision Date | 11/06/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|