Device Classification Name |
transcranial magnetic stimulator
|
510(k) Number |
K173620 |
Device Name |
Mag Vita TMS Therapy System w/Theta Burst Stimulation |
Applicant |
Tonica Elektronik A/S |
Lucernemarken 15 |
Farum,
DK
3520
|
|
Applicant Contact |
Sanne Barsballe Jessen |
Correspondent |
Tonica Elektronik A/S |
Lucernemarken 15 |
Farum,
DK
3520
|
|
Correspondent Contact |
Sanne Barsballe Jessen |
Regulation Number | 882.5805
|
Classification Product Code |
|
Date Received | 11/22/2017 |
Decision Date | 08/14/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|