510(k) Report

Devices descending from K243781

2 later devices reach HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+1K253034HemoSphere Stream ModuleEdwards Lifesciences20250—