510(k) Report

Devices descending from K082077

6 later devices reach BT3/6, BT12 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130878CloudekgMakromed, Inc.20140—
+1K110065Spaulding IQ ElectrocardiographSpaulding Clinical Research, LLC20112—
+1K100813QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS Card UsbPulse Biomedical, Inc.20101—
+2K150564Spaulding Electrocardiograph 2100iQSpaulding Clinical Research, LLC20151—
+2K142352CardiacLinxRoss Medical Technology, Inc.20150—
+3K163607ECG Acquisition SystemsVales & Hills Biomedical Tech., Ltd.20170—