Device Classification Name |
transcranial magnetic stimulation system for obsessive-compulsive disorder
|
510(k) Number |
K212289 |
Device Name |
NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar |
Applicant |
Neuronetics, Inc |
3222 Phoenixville Pike |
Malvern,
PA
19355
|
|
Applicant Contact |
Cory Anderson |
Correspondent |
Neuronetics, Inc |
3222 Phoenixville Pike |
Malvern,
PA
19355
|
|
Correspondent Contact |
Robin Fatzinger |
Regulation Number | 882.5802
|
Classification Product Code |
|
Date Received | 07/21/2021 |
Decision Date | 05/06/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|