510(k) Report

Devices descending from K110499

2 later devices reach CG-5108 Act-3L Continuous Ecg Monitor and Arrhythmia Detector through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143359CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia DetectorLifewatch Technologies, Ltd.20151—
+2K170565LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3LLifewatch Services, Inc.20170—