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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 transcranial magnetic stimulator for the treatment of migraine headache
De Novo Number DEN130022
510(K) Number K130556
Device Name NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR
Requester
ENEURA THERAPEUTICS
2690 pheasant road
orono,  MN  55331
Contact larry getlin
Regulation Number882.5808
Classification Product Code
OKP  
Date Received03/05/2013
Decision Date 12/13/2013
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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