Device Classification Name |
electromechanical arm for a transcranial magnetic stimulation system
|
510(k) Number |
K182768 |
Device Name |
TMS-Cobot TS MV |
Applicant |
Axilum Robotics |
8 rue Schertz |
Strasbourg,
FR
67100
|
|
Applicant Contact |
Romuald Ginhoux |
Correspondent |
Hogan Lovells US LLP |
1735 Market Street, 23rd Floor |
Philadelphia,
PA
19103
|
|
Correspondent Contact |
Janice Hogan |
Regulation Number | 882.5805
|
Classification Product Code |
|
Date Received | 09/28/2018 |
Decision Date | 02/17/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|