510(k) Report

Devices descending from K914577

8 later devices reach Rhythmscan Precision 6000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031466Iqmark Digital HolterBrentwood Medical Technology Corp.20036—
+1K973751MT-200Schiller America, Inc.19980—
+2K142693ZywieAI Software LibraryZywie, Inc.20150—
+2K063035Sleuth Implantable Ecg Monitoring SystemTransnoma Medical, Inc.20073—
+2K062088Premier 11 HolterDiagnostic Monitoring Software20060—
+3K083828Sleuth at Implantable Cardiac Monitoring System -6 CM and 8CM Antenna, Personal…Transoma20091—
+3K073147Sleuth Implantable Ecg System-8 CM Accessory Kit, Model 3000-08Transoma Medical20072—
+4K091206Sleuth at Implantable Cardiac Monitoring System-6 and 8CM Antenna, Personal Diagnostic…Transoma Medical20090—