510(k) Report

Devices descending from K960968

31 later devices reach Medi-Trace 200, Medi-Trace 200-30 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063044Cardiobelt Electrode BeltMonebo Technologies, Inc.200718—
+1K043361Accuheart Electrode BeltAdvanced Bioelectric Corporation200521—
+1K023503Skintact Ecg ElectrodeLeonhard Lang GmbH20028—
+2K113045BioharnessZephyr Technology Corporation20122—
+2K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp.200914—
+2K073104Skintact and Various Other TradenamesLeonhard Lang GmbH20072—
+2K071576Textronics Ecg ElectrodeTextronics, Inc.20070—
+2K062760Ori F6T Dry Ecg Monitoring ElectrodeOrbital Research, Inc.20060—
+2K023920SkintactLeonhard Lang GmbH20035—
+3K171244PhysiotraceNimbleheart, Inc.20170—
+3K122763Physiological Data ProcessorZephyr Technology Corporation20130—
+3K121617SensicardiacDiacoustic Medical (Pty)201210—
+3K110704SENSIDiacoustic Medical Devices (Pty), Ltd.201113—
+3K090496Qwiklead Reusable Electrocardiograph Electrode PatchCardiac Lead Technologies, Inc.20090—
+3K080106Skintact Pre-Wired Ecg Electrodes with Conductive AdhesiveLeonhard Lang GmbH20080—
+3K030509Skintact Ecg Tab ElectrodeLeonhard Lang GmbH20034—
+4K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd.20139—
+4K131287CardiosleeveRijuven Corp20131—
+4K093327Intco Tab ElectrodeShanghai Intco Electrode Manufacturing Co., Ltd.20100—
+4K092291Skintact and Various Other TradenamesLeonhard Lang GmbH20090—
+4K040784Protab Ecg Tabb ElectrodeBio Protech, Inc.20041—
+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—