Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K122288
Device Classification Name
Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
More FDA Info for this Device
510(K) Number
K122288
Device Name
Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
Applicant
BRAINSWAY, LTD
20 HATA'AS ST. (POB 124)
KFAR SABA 44425 IL
Other 510(k) Applications for this Company
Contact
AHAVA STEIN
Other 510(k) Applications for this Contact
Regulation Number
882.5805
More FDA Info for this Regulation Number
Classification Product Code
OBP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/30/2012
Decision Date
01/07/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact