510(k) Report

Devices descending from K101052

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132229Omni Patent MonitorsInfinium Medical20142—
+1K103268Omni ExpressInfinium Medical20105—
+2K153079Axeo 3 Patient MonitorAxeo Medical Technologies, LLC20160—
+2K142244Cleo Patient MonitorInfinium Medical201501
+2K103737Omni II Patient MonitorInfinium Medical20114—
+3K112329Omni Patient MonitorInfinium Medical20113—