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 spinal imaging system for neuraxial procedures
De Novo Number DEN220009
Device Name VerTouch Spinal Imaging Device
Requester
intuitap medical, inc.
1940 fountain view drive
houston,  TX  77057
Contact jessica traver
Regulation Number868.1985
Classification Product Code
QXD  
Date Received02/01/2022
Decision Date 01/19/2024
Decision granted (DENG)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Reclassification Order Reclassification Order
Type Direct
-
-