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FDA 510(k) Application Details - K143531
Device Classification Name
Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
More FDA Info for this Device
510(K) Number
K143531
Device Name
Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
Applicant
MAGSTIM COMPANY LIMITED
SPRING GARDENS, WHITLAND
CARMARTHENSHIRE SA34 OHR GB
Other 510(k) Applications for this Company
Contact
Charles Hounsell
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
12/12/2014
Decision Date
05/08/2015
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
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