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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name non-invasive evoked response brain stimulator
De Novo Number DEN250002
Device Name Delphi-MD System
Requester
quantalx neuroscience, ltd.
1 hatachana kfar saba
kfar-saba,  IL 4453001
Contact iftach dolev
Regulation Number882.1860
Classification Product Code
SFN  
Date Received01/03/2025
Decision Date 08/20/2025
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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