510(k) Report

Devices descending from K955023

19 later devices reach Brentwood PC-Ecg through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103640Midmark IqecgBrentwood Medical Technology Corp.201131
+1K093339Eli PC ElectrocardiographMortara Instrument, Inc.201061
+1K020366Global Ecg Management System (Gems)Cardiocomm Solutions, Inc.20021—
+1K013354GlobalcardioCardiocomm Solutions, Inc.20025—
+2K143436InvisionECG SystemInvisionheart, Inc.20150—
+2K123217CardeascreenCardea Associates, Inc.20130—
+2K120865Rscribe ElectrocardiographMortara Instrument, Inc.201221
+2K113234Mobcardio SystemMobhealth Incorporation20110—
+2K111320GlobalcardioCardiocomm Solutions, Inc.20113—
+2K110065Spaulding IQ ElectrocardiographSpaulding Clinical Research, LLC20112—
+2K033037Modification to GlobalcardioCardiocomm Solutions, Inc.20034—
+2K022297Global Ecg Management System (Gems)Cardiocomm Solutions, Inc.20020—
+3K260250QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)QT Medical, Inc.20260—
+3K160746CARDIOLINE touchECGCardioline S.P.A20160—
+3K150564Spaulding Electrocardiograph 2100iQSpaulding Clinical Research, LLC20151—
+3K122632Guava IICardiocomm Solutions, Inc.20142—
+4K163607ECG Acquisition SystemsVales & Hills Biomedical Tech., Ltd.20170—
+4K162571Bioflux SoftwareBiotricity, Inc.20161—
+5K201040Bioflux Software IIBiotricity20200—