510(k) Report

Devices descending from K161431

5 later devices reach SimplECG through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201669SimpleSENSENanowear, Inc.20203—
+1K173248CardioskinBioserenity Sas20180—
+2K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.20250—
+2K212160SimpleSENSE PlatformNanowear, Inc.20211—
+3K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—