510(k) Report

Devices descending from DEN180067

2 later devices reach Mucosal Integrity Conductivity (MI) Test System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233974Mucosal Impedance Measurement SystemAlandra Medical Sapi DE CV20240—
+1K230056MiVu™ Esophageal Endo CapDiversatek Healthcare20230—