Device Classification Name |
transcranial magnetic stimulation system for obsessive-compulsive disorder
|
510(k) Number |
K193006 |
Device Name |
MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system |
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 | 882.5802
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/28/2019 |
Decision Date | 08/09/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|