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 electrocardiograph software for over-the-counter use
De Novo Number DEN180044
Device Name ECG App
Requester
Apple Inc
c/o biologics consulting group
400 n washington st., suite 100
alexandria,  VA  22314
Contact donna-bea tillman
Regulation Number870.2345
Classification Product Code
QDA  
Date Received08/14/2018
Decision Date 09/11/2018
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
-
-