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 esophageal, mucosal, electrical characterization
Regulation Description Esophageal tissue characterization system.
Definition The esophageal tissue characterization system is intended for obtaining measurements of electrical properties within esophageal tissue.
Product CodeQIS
Regulation Number 876.1450
Device Class 2


Premarket Reviews
ManufacturerDecision
ALANDRA MEDICAL SAPI DE CV
  SUBSTANTIALLY EQUIVALENT 1
DIVERSATEK HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1

-
-