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 source localization software for electroencephalograph or magnetoencephalograph
Regulation Description Electroencephalograph.
Definition Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization
Product CodeOLX
Regulation Number 882.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
BRAIN ELECTROPHYSIOLOGY LABORATORY COMPANY, LLC
  SUBSTANTIALLY EQUIVALENT 1
CLOUDS OF CARE
  SUBSTANTIALLY EQUIVALENT 1
LVIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEGIN OY
  SUBSTANTIALLY EQUIVALENT 1
RICOH COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1

-
-