510(k) Report

Devices descending from K080047

11 later devices reach Cardiosen'c through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113514SmartheartShl Telemedicine International, Ltd.201210—
+2K180157QT ECGQT Medical, Inc.20182—
+2K142476Master Caution Device MCDHealthwatch, Ltd.20156—
+3K220795QT ECGQT Medical, Inc.20221—
+3K173248CardioskinBioserenity Sas20180—
+3K161431SimplECGNanowear, Inc.20165—
+4K233521QT Ecg (QTERD100)QT Medical, Inc.20230—
+4K201669SimpleSENSENanowear, Inc.20203—
+5K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.20250—
+5K212160SimpleSENSE PlatformNanowear, Inc.20211—
+6K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—