-
New Search
Back To Search Results
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
Predetermined Change
Control Plan Authorized
No
-