510(k) Report

Devices descending from K010436

16 later devices reach Tempus 2000 Patient Monitor, Model 00-0001; Tempus Monitoring Station, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082718Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd.200814—
+1K033410Tempus 2000 Patient Monitor, Model 00-0002Remote Diagnostic Technologies, Ltd.200415—
+2K113105Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd.20118—
+2K090285Sonicaid FM820 and FM830 EncoreHuntleigh Healthcare, Ltd.20094—
+3K200975Sonicaid Team3 Antepartum, Sonicaid Team3 IntrapartumHuntleigh Healthcare Limited20203—
+3K152124Tempus IC2Remote Diagnostics Technologies, Ltd.20157—
+4K241368Sonicaid Team3Huntleigh Healthcare, Ltd.20252—
+4K152645Dictum HealthDictum Health, Inc.20166—
+5K250777Sonicaid Team3Huntleigh Healthcare, Ltd.20251—
+5K170798Dictum HealthDictum Health, Inc.20175—
+6K253021ANNE MaternalSibel Health, Inc.20260—
+6K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+7K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+8K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+8K240901StethophoneSparrow Acoustics, Inc.20241—
+9K252595Stethophone ProSparrow Acoustics, Inc.20250—