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FDA 510(k) Application Details - K212723
Device Classification Name
Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
More FDA Info for this Device
510(K) Number
K212723
Device Name
Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
Applicant
BTL Industries Inc.
362 Elm Street
Marlborough, MA 01752 US
Other 510(k) Applications for this Company
Contact
David Chmel
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
08/27/2021
Decision Date
03/04/2022
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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