510(k) Report

Devices descending from K082421

2 later devices reach Heartsuite Hemodynamics 7.10 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152864Merge HemoMerge Healthcare Incorporated201612
+2K233326Merge Hemo, Model RCSV2Merge Healthcare Incorporated202401