510(k) Report

Devices descending from K915632

27 later devices reach Paceart CPTS-86/12 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072950Cygnus 12 Lead Ecg ModuleCygnus, LLC20080—
+1K020534Medstar System, Models 533-300Cybernet Medical2003104
+1K982384MercatorHarley Street Software, Ltd.19997—
+1K982090Paceart Home Trak Plus Easi Event Recorder SystemPaceart, Inc.19996—
+2K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.20250—
+2K051544Vitalcaregiving SystemAdvanced Monitoring Caregiving, Inc.20057—
+2K050951Medstar 220, Model 533-220; Medstar 230, Model 533-230; Medstar 360, Model 533-360…Cibernet Systems Corp.200504
+2K041854MPM SystemAerotel Medical Systems, Ltd.20048—
+2K022297Global Ecg Management System (Gems)Cardiocomm Solutions, Inc.20020—
+2K020213Netlink/NetscanRozinn Electronics, Inc.20024—
+2K013354GlobalcardioCardiocomm Solutions, Inc.20025—
+3K233446AMC Health CareConsoleAmc Health20240—
+3K151839AMC Health VitalCaregiving SystemAmc Health20161—
+3K111320GlobalcardioCardiocomm Solutions, Inc.20113—
+3K063008Health Check KioskXperex Corporation20074—
+3K042002Synescope, Easyscope, Synecom, HolterreaderEla Medical, Inc.20043—
+3K033037Modification to GlobalcardioCardiocomm Solutions, Inc.20034—
+4K193177CER-SCardiocalm20202—
+4K143108HealthGuard-15Futrex, Inc.20150—
+4K122632Guava IICardiocomm Solutions, Inc.20142—
+4K113402Solohealth StationSolohealth, Inc.20120—
+4K101198Csi Managed Health System Model: Csi Model 9KComputerized Screening, Inc.20101—
+5K213861CER-SCardiocalm Srl20221—
+5K153600Consult Station TSH4D Sas20170—
+5K162571Bioflux SoftwareBiotricity, Inc.20161—
+6K243312CER-SCardiocalm Srl20250—
+6K201040Bioflux Software IIBiotricity20200—