510(k) Report

Devices descending from K963725

210 later devices reach Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K201669SimpleSENSENanowear, Inc.20203—
+8K152491MoMe Software PlatformInfobionic, Inc.20150—
+8K143359CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia DetectorLifewatch Technologies, Ltd.20151—
+9K252859ZEUS Platform (FG0501US)iRhythm Technologies, Inc.20260—
+9K253141DeepRhythmAIMedicalgorithmics S.A.20250—
+9K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.20250—
+9K252595Stethophone ProSparrow Acoustics, Inc.20250—
+9K212160SimpleSENSE PlatformNanowear, Inc.20211—
+9K170565LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3LLifewatch Services, Inc.20170—
+10K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—