Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Device Classification Name evoked photon image capture device
De Novo Number DEN150004
Device Name EPIC ClearView System
Requester
EPIC RESEARCH & DIAGNOSTICS, INC.
7659 e pinnacle peak rd. suite 115
scottsdale,  AZ  85255
Contact nancy rizzo
Regulation Number882.1561
Classification Product Code
PNA  
Date Received01/13/2015
Decision Date 07/15/2016
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
-
-