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FDA 510(k) Application Details - K220819
Device Classification Name
Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
More FDA Info for this Device
510(K) Number
K220819
Device Name
Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
Applicant
BrainsWay Ltd.
19 Hartom St. (Bynet Bldg) Har Hotzvim
Jerusalem 9777518 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
03/21/2022
Decision Date
08/26/2022
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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