FDA 510(k) Application Details - DEN150004

Device Classification Name

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510(K) Number DEN150004
Device Name EPIC ClearView System
Applicant EPIC RESEARCH & DIAGNOSTICS, INC.
7659 E PINNACLE PEAK RD. SUITE 115
SCOTTSDALE, AZ 85255 US
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Contact NANCY RIZZO
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Regulation Number

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Classification Product Code PNA
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Date Received 01/13/2015
Decision Date 07/15/2016
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 DEN150004


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