510(k) Report

Devices descending from K103737

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153079Axeo 3 Patient MonitorAxeo Medical Technologies, LLC20160—
+1K132229Omni Patent MonitorsInfinium Medical20142—
+1K112329Omni Patient MonitorInfinium Medical20113—
+2K142244Cleo Patient MonitorInfinium Medical201501