Device Classification Name |
Transcranial Magnetic Stimulator
|
510(k) Number |
K122288 |
FOIA Releasable 510(k) |
K122288
|
Device Name |
BRAINSWAY DEEP TMS SYSTEM |
Applicant |
BRAINSWAY, LTD |
20 HATA'AS ST. (POB 124) |
KFAR SABA,
IL
44425
|
|
Applicant Contact |
AHAVA STEIN |
Correspondent |
BRAINSWAY, LTD |
20 HATA'AS ST. (POB 124) |
KFAR SABA,
IL
44425
|
|
Correspondent Contact |
AHAVA STEIN |
Regulation Number | 882.5805
|
Classification Product Code |
|
Date Received | 07/30/2012 |
Decision Date | 01/07/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT00927173
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|