510(k) Report

Devices descending from K112329

3 later devices reach Omni Patient Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132229Omni Patent MonitorsInfinium Medical20142—
+2K153079Axeo 3 Patient MonitorAxeo Medical Technologies, LLC20160—
+2K142244Cleo Patient MonitorInfinium Medical201501