510(k) Report

Devices descending from K920627

24 later devices reach Model Eli 100 Electrocardiograph through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101115Eli 150 Electrocardiograph Model Eli 150Mortara Instrument, Inc.201001
+1K982470Ecg Electrodes ApronTapuz Medical Technology, Ltd.199822—
+2K043361Accuheart Electrode BeltAdvanced Bioelectric Corporation200521—
+3K071576Textronics Ecg ElectrodeTextronics, Inc.20070—
+3K063044Cardiobelt Electrode BeltMonebo Technologies, Inc.200718—
+3K062760Ori F6T Dry Ecg Monitoring ElectrodeOrbital Research, Inc.20060—
+4K113045BioharnessZephyr Technology Corporation20122—
+4K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp.200914—
+5K171244PhysiotraceNimbleheart, Inc.20170—
+5K122763Physiological Data ProcessorZephyr Technology Corporation20130—
+5K121617SensicardiacDiacoustic Medical (Pty)201210—
+5K110704SENSIDiacoustic Medical Devices (Pty), Ltd.201113—
+6K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd.20139—
+6K131287CardiosleeveRijuven Corp20131—
+7K201299HD StethHd Medical, Inc.20200—
+7K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+7K181988eMurmur IDCsd Labs GmbH20197—
+8K230823AusculThing ACCAusculthing OY20230—
+8K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+8K220766eMurmur Heart AICsd Labs GmbH20221—
+9K252284eMurmur Heart AICsd Labs20250—
+9K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+9K240901StethophoneSparrow Acoustics, Inc.20241—
+10K252595Stethophone ProSparrow Acoustics, Inc.20250—