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 cardiac device identifier
De Novo Number DEN260007
Device Name SmartRead(TM) Medical Device Identifier (4100)
Requester
bridgesource medical corporation
3301 northland dr.
suite 214
austin,  TX  78751
Contact john walmsley
Regulation Number870.3645
Classification Product Code
SJJ  
Date Received03/24/2026
Decision Date 09/29/2026
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Direct
Predetermined Change
Control Plan Authorized		 No
-
-