510(k) Report

Devices descending from K973318

16 later devices reach Mobimed System, (Pegasus and Polaris) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033410Tempus 2000 Patient Monitor, Model 00-0002Remote Diagnostic Technologies, Ltd.200415—
+2K082718Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd.200814—
+3K113105Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd.20118—
+3K090285Sonicaid FM820 and FM830 EncoreHuntleigh Healthcare, Ltd.20094—
+4K200975Sonicaid Team3 Antepartum, Sonicaid Team3 IntrapartumHuntleigh Healthcare Limited20203—
+4K152124Tempus IC2Remote Diagnostics Technologies, Ltd.20157—
+5K241368Sonicaid Team3Huntleigh Healthcare, Ltd.20252—
+5K152645Dictum HealthDictum Health, Inc.20166—
+6K250777Sonicaid Team3Huntleigh Healthcare, Ltd.20251—
+6K170798Dictum HealthDictum Health, Inc.20175—
+7K253021ANNE MaternalSibel Health, Inc.20260—
+7K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+8K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+9K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+9K240901StethophoneSparrow Acoustics, Inc.20241—
+10K252595Stethophone ProSparrow Acoustics, Inc.20250—