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
De Novo Number DEN240062
Device Name Minder System
Requester
epi-minder pty ltd
384-388 albert st
melbourne,  AU 3002
Contact tracy cameron
Classification Product Code
SEM
Date Received10/18/2024
Decision Date 04/17/2025
Decision granted (DENG)
Review Advisory Committee Neurology
Type Direct
-
-