510(k) Report

Devices descending from K170874

5 later devices reach Eko Model E5 System (EME5), Eko DUO through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230111CORE 500 Digital StethoscopeEko Devices, Inc.20231—
+1K193518KosmosEchoNous, Inc.20201—
+1K182040Coala Heart MonitorCoala Life AB20190—
+2K233609CORE 500 Digital StethoscopeEko Health, Inc.20240—
+2K212100KosmosEchoNous, Inc.202101