510(k) Report

Devices descending from K042128

16 later devices reach Modification to Zargis Acoustic Cardioscan (Zac) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp.200914—
+1K060197Zargis Acoustic Cardioscan (Zac), Model Zac 6.28Zargis Medical Corp.200615—
+2K121617SensicardiacDiacoustic Medical (Pty)201210—
+2K110704SENSIDiacoustic Medical Devices (Pty), Ltd.201113—
+3K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd.20139—
+3K131287CardiosleeveRijuven Corp20131—
+4K201299HD StethHd Medical, Inc.20200—
+4K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+4K181988eMurmur IDCsd Labs GmbH20197—
+5K230823AusculThing ACCAusculthing OY20230—
+5K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+5K220766eMurmur Heart AICsd Labs GmbH20221—
+6K252284eMurmur Heart AICsd Labs20250—
+6K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+6K240901StethophoneSparrow Acoustics, Inc.20241—
+7K252595Stethophone ProSparrow Acoustics, Inc.20250—