510(k) Report

Devices descending from K013725

16 later devices reach Meditron II Thesterthoscope System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110704SENSIDiacoustic Medical Devices (Pty), Ltd.201113—
+1K090493SignalZargis Medical Corp.20091—
+2K131287CardiosleeveRijuven Corp20131—
+2K121617SensicardiacDiacoustic Medical (Pty)201210—
+2K100531Viscope, Model 100P,100SHd Medical Services (India) Pvt.Ltd20100—
+3K201299HD StethHd Medical, Inc.20200—
+3K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd.20139—
+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—