Device Classification Name |
transcranial magnetic stimulator
|
510(k) Number |
K130233 |
Device Name |
NEUROSTAR TMS THERAPY SYSTEM |
Applicant |
NEURONETICS |
31 GENERAL WARREN BLVD |
malvern,
PA
19355 -1245
|
|
Applicant Contact |
judy p ways, ph.d. |
Correspondent |
NEURONETICS |
31 GENERAL WARREN BLVD |
malvern,
PA
19355 -1245
|
|
Correspondent Contact |
judy p ways, ph.d. |
Regulation Number | 882.5805
|
Classification Product Code |
|
Date Received | 01/30/2013 |
Decision Date | 04/30/2013 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|