510(k) Report

Devices descending from K953649

20 later devices reach Disposable Ecg Electrode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030316Audicor Cor Sensor (and Accessory Adaptor)Inovise Medical, Inc.20032—
+1K013725Meditron II Thesterthoscope SystemMeditron AS200216—
+2K110704SENSIDiacoustic Medical Devices (Pty), Ltd.201113—
+2K090493SignalZargis Medical Corp.20091—
+2K080602Audicor Sensor, Models: 2.0, 3.0Inovise Medical, Inc.20081—
+3K131287CardiosleeveRijuven Corp20131—
+3K121617SensicardiacDiacoustic Medical (Pty)201210—
+3K103516Audicor Sensor-Adapter Model Audicor Sensor-Adapter 4.0Inovise Medical, Inc.20110—
+3K100531Viscope, Model 100P,100SHd Medical Services (India) Pvt.Ltd20100—
+4K201299HD StethHd Medical, Inc.20200—
+4K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd.20139—
+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—