510(k) Report

Devices descending from K093339

6 later devices reach Eli PC Electrocardiograph through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120865Rscribe ElectrocardiographMortara Instrument, Inc.201221
+1K110065Spaulding IQ ElectrocardiographSpaulding Clinical Research, LLC20112—
+2K260250QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)QT Medical, Inc.20260—
+2K160746CARDIOLINE touchECGCardioline S.P.A20160—
+2K150564Spaulding Electrocardiograph 2100iQSpaulding Clinical Research, LLC20151—
+3K163607ECG Acquisition SystemsVales & Hills Biomedical Tech., Ltd.20170—