510(k) Report

Devices descending from K063035

3 later devices reach Sleuth Implantable Ecg Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083828Sleuth at Implantable Cardiac Monitoring System -6 CM and 8CM Antenna, Personal…Transoma20091—
+1K073147Sleuth Implantable Ecg System-8 CM Accessory Kit, Model 3000-08Transoma Medical20072—
+2K091206Sleuth at Implantable Cardiac Monitoring System-6 and 8CM Antenna, Personal Diagnostic…Transoma Medical20090—