510(k) Report

Devices descending from K113514

10 later devices reach Smartheart through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180157QT ECGQT Medical, Inc.20182—
+1K142476Master Caution Device MCDHealthwatch, Ltd.20156—
+2K220795QT ECGQT Medical, Inc.20221—
+2K173248CardioskinBioserenity Sas20180—
+2K161431SimplECGNanowear, Inc.20165—
+3K233521QT Ecg (QTERD100)QT Medical, Inc.20230—
+3K201669SimpleSENSENanowear, Inc.20203—
+4K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.20250—
+4K212160SimpleSENSE PlatformNanowear, Inc.20211—
+5K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—