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FDA 510(k) Application Details - K150641
Device Classification Name
Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
More FDA Info for this Device
510(K) Number
K150641
Device Name
Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
Applicant
TONICA ELEKTRONIK A/S
LUCERNEMARKEN 15
FARUM 3520 DK
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Contact
Lise Terkelsen
Other 510(k) Applications for this Contact
Regulation Number
882.5805
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Classification Product Code
OBP
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More FDA Info for this Product Code
Date Received
03/11/2015
Decision Date
07/31/2015
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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