510(k) Report

Devices descending from K190593

4 later devices reach Zio XT ECG Monitoring System, Zio AT ECG Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202527Zio ECG Utilization Software (ZEUS) SystemiRhythm Technologies, Inc.20213—
+2K222389ZEUS SystemiRhythm Technologies, Inc.20231—
+2K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.20220—
+3K252859ZEUS Platform (FG0501US)iRhythm Technologies, Inc.20260—