510(k) Report

Devices descending from K113105

8 later devices reach Tempusic Patient Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152124Tempus IC2Remote Diagnostics Technologies, Ltd.20157—
+2K152645Dictum HealthDictum Health, Inc.20166—
+3K170798Dictum HealthDictum Health, Inc.20175—
+4K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+5K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+6K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+6K240901StethophoneSparrow Acoustics, Inc.20241—
+7K252595Stethophone ProSparrow Acoustics, Inc.20250—