Device Classification Name |
Transcranial Magnetic Stimulator
|
510(k) Number |
K213543 |
Device Name |
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health |
Applicant |
Neuronetics, Inc |
3222 Phoenixville Pike |
Malvern,
PA
19355
|
|
Applicant Contact |
Fred Cowdery |
Correspondent |
Neuronetics, Inc |
3222 Phoenixville Pike |
Malvern,
PA
19355
|
|
Correspondent Contact |
Fred Cowdery |
Regulation Number | 882.5805
|
Classification Product Code |
|
Date Received | 11/08/2021 |
Decision Date | 12/10/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|