510(k) Report

Devices descending from K043361

21 later devices reach Accuheart Electrode Belt through their predicates, nearest generation first.

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