Device Classification Name |
stimulator, nerve, battery-powered
|
510(k) Number |
K213049 |
Device Name |
STIMPOD NMS450 Nerve Stimulator |
Applicant |
Xavant Technology (Pty) Ltd |
Unit 102 Tannery Industrial Park, 309 Derdepoort Road |
Silverton |
Pretoria,
ZA
0184
|
|
Applicant Contact |
Roche Janse van Rensburg |
Correspondent |
Xavant Technology (Pty) Ltd |
Unit 102 Tannery Industrial Park, 309 Derdepoort Road |
Silverton |
Pretoria,
ZA
0184
|
|
Correspondent Contact |
Roche Janse van Rensburg |
Regulation Number | 868.2775
|
Classification Product Code |
|
Date Received | 09/22/2021 |
Decision Date | 10/16/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|