510(k) Report

Devices descending from K110704

13 later devices reach SENSI through their predicates, nearest generation first.

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