510(k) Report

Devices descending from K111159

2 later devices reach Heartcheck Pen Handheld Ecg with Gems Home through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181310HeartCheck Cardi Beat ECG Monitor with GEMS MobileCardiocomm Solutions, Inc.20190—
+1K121009Heartcheck Ecg Pen with Gems HomeCardiocomm Solutions, Inc.20120—