510(k) Report

Devices descending from K081703

10 later devices reach Myglucohealth Glucose Monitoring Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143169MyGlucoHealth Wireless SystemEntra Health Systems20160—
+1K113105Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd.20118—
+2K152124Tempus IC2Remote Diagnostics Technologies, Ltd.20157—
+3K152645Dictum HealthDictum Health, Inc.20166—
+4K170798Dictum HealthDictum Health, Inc.20175—
+5K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+6K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+7K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+7K240901StethophoneSparrow Acoustics, Inc.20241—
+8K252595Stethophone ProSparrow Acoustics, Inc.20250—