• 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 physiological signal based seizure monitoring system
De Novo Number DEN140033
Device Name Companion
115 n loop, 1604 e.,suite 1203
san antonio,  TX  78232
Contact mike girouard
Regulation Number882.1580
Classification Product Code
Date Received11/10/2014
Decision Date 02/16/2017
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct