Device Classification Name |
electrode, depth
|
510(k) Number |
K170959 |
Device Name |
DIXI Medical Microdeep Depth Electrode |
Applicant |
DIXI Medical |
2A route de Pouligney |
Chaudefontaine,
FR
|
|
Applicant Contact |
Lucie Petegnief |
Correspondent |
Experien Group, LLC |
224 Airport Parkway, Suite 250 |
San Jose,
CA
95110
|
|
Correspondent Contact |
Valerie Defiesta-Ng |
Regulation Number | 882.1330
|
Classification Product Code |
|
Date Received | 03/31/2017 |
Decision Date | 11/24/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|