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FDA 510(k) Application Details - DEN220066
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN220066
Device Name
BrainSee
Applicant
Darmiyan, Inc.
1425 Berkeley Way
Berkeley, CA 94702 US
Other 510(k) Applications for this Company
Contact
Kaveh Vejdani
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QWT
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More FDA Info for this Product Code
Date Received
09/29/2022
Decision Date
01/11/2024
Decision
DENG -
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
FDA Source Information for DEN220066
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