510(k) Report

Devices descending from K160064

3 later devices reach MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20231—
+1K231276SmartCardia 7L PlatformSmartcardia SA20230—
+2K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.20250—