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

TPLC - Total Product Life Cycle
  • 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 show TPLC since Back to Search Results
Device computerized cognitive assessment aid for concussion
Definition For use as an assessment aid in the management of concussion.
Product CodePOM
Regulation Number 882.1471
Device Class 2


Premarket Reviews
ManufacturerDecision
IMPACT APPLICATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VISTA LIFESCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1

-
-