FDA 510(k) Application Details - DEN220066

Device Classification Name

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510(K) Number DEN220066
Device Name BrainSee
Applicant Darmiyan, Inc.
1425 Berkeley Way
Berkeley, CA 94702 US
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Contact Kaveh Vejdani
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Regulation Number

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Classification Product Code QWT
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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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