510(k) Report

Devices descending from K071011

1 later device reach Modification to: Braemar ER900 Series Enhanced Algorithm Ecg Event Recorder through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112601Intricon Datrix Sirona Event/ Holter RecorderIntricon Datrix Corporation20110—