510(k) Report

Devices descending from K993618

43 later devices reach DXP1000 Holter Recorder through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113176Mysense HeartCardiac Science Corporation201116—
+1K083382Chroma, Model: RZ153CScottcare Corporation20090—
+1K070818MEDILOGAR4, MEDILOGAR12Tom Medical Entwicklungs GmbH200714—
+1K031074Digital Ambulatory Ecg (Holter) RecorderDatrix20031—
+1K032276Click HolterRemco Italia S.P.A.20030—
+1K030856ER800 Series Ecg Event RecorderBraemar Corp.20036—
+2K253562medilogFDSchiller AG20260—
+2K131190MypatchDms-Service, LLC201315—
+2K112601Intricon Datrix Sirona Event/ Holter RecorderIntricon Datrix Corporation20110—
+2K083820Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-CVasomedical, Inc.200912—
+2K061293Telaheart Digital RecorderNorth East Monitoring, Inc.20065—
+3K171410ePatchBraemar Manufacturing, LLC20187—
+3K160704myPatch-sDms-Service, LLC201614—
+3K142424DR300 Holter MonitorNorth East Monitoring, Inc.20143—
+3K111180Vasomedical-Biox 12- Channel Ambulatory Ecg Holter Recorder Model 1304, Vasomedical-Biox…Vasomedical, Inc.20110—
+3K101022Pulmotrack 5050 Wholter, Model 5050Karmelsonix20106—
+3K092785Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis Software…Vasomedical, Inc.20103—
+3K070014Auto Detect for Telaheart DR200/E-aNorth East Monitoring, Inc.20070—
+4K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.20260—
+4K231104ABPMproSomnomedics GmbH20230—
+4K231289S-Patch Ex Wearable ECG PatchWellysis Corp.20233—
+4K211709BiotresBiotricity20222—
+4K163535my Patch slDms-Service, LLC20175—
+4K151787Holter SystemEdan Instruments, Inc.20162—
+4K110525Vitalograph Model 7100 - VitalojakVitalograph (Ireland), Ltd.20115—
+4K111096Vasomedical-Biox Combined 12 Channel Ambulatory Ecg and Blood Pressure Recorder Model…Vasomedical, Inc.20111—
+5K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd.20260—
+5K253384mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7…Seers Technology Co., Ltd.20260—
+5K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+5K253293VitaloJAK Clinic (Model 7100)Vitalograph, Ltd.20250—
+5K233864ASSURE Wearable ECGKestra Medical Technologies, Inc.20240—
+5K233906S-Patch (S-Patch ExL)Wellysis Corp.20240—
+5K230184Holter ECG and ABP SystemEdan Instruments, Inc.20230—
+5K222017BiotresBiotricity20220—
+5K210758Q PatchMedicalgorithmics S.A.20221—
+5K203168LifeLens Wireless ECG MonitorLifeLens Technologies, Inc.20211—
+5K202456M5 RecorderGlobal Instrumentation, LLC20200—
+5K201077Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs20203—
+6K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+6K252839ZywieZ3 Sensor & AdhesiveZywie, Inc.20260—
+6K220893Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs, Inc.20222—
+7K223382AeviceMDAevice Health Pte., Ltd.20231—
+8K243603AeviceMDAevice Health Pte., Ltd.20250—