510(k) Report

Devices descending from K001317

25 later devices reach ARIA through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021470Seer Light Compact Digital Holter RecorderGeneral Electric Medical Systems Information Techn200224—
+2K100266Actiwave 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, Actiwave Cardio Model 08-514, 08-521…Camntech, Ltd.20100—
+2K073545Audicor, Hemo Ambulatory MonitorInovise Medical, Inc.200811—
+2K050731Seer Light Extend Compact Digital Holter SystemGe Medical Systems Information Technologies200510—
+3K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+3K173156Integrated CardioRespiratory SystemSensydia, Inc.20180—
+3K130785SEER 1000Getemed Medizin- Und Informationstechnik AG20130—
+3K124060Medical Gorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A.20135—
+3K112921Medicalgorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A.20127—
+3K110569Audicor Cpam (Cardiopulmonary Ambulatory Monitor)Inovise Medical, Inc.20114—
+3K101024Kenz CARDY302 MaxSuzuken Co., Ltd.20110—
+4K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+4K173969Medicalgorithmics Unified Cardiac Rehabilitation SystemMedicalgorithmics S.A.20180—
+4K171019ScioCardio ECG TransmitterSynergen Technology Labs, LLC20180—
+4K152550Medicalgorithmics Unified Arrhythmia Diagnosic SystemMedicalgorithmics S.A.20153—
+4K120462Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…Inovise Medical, Inc.20123—
+5K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+5K240901StethophoneSparrow Acoustics, Inc.20241—
+5K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.20201—
+5K193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.20200—
+5K131883Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc.20141—
+5K130660Audicor Cpam with SDB (Single Sensor)Inovise Medical, Inc.20130—
+6K252595Stethophone ProSparrow Acoustics, Inc.20250—
+6K241179Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)VivaQuant, Inc.20250—
+6K151433AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc.20160—