510(k) Report

Devices descending from K982975

5 later devices reach Digital Ecg Holter Recorder, Model DR512 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062007DMS 300-7Diagnostic Monitoring Software20062—
+1K031074Digital Ambulatory Ecg (Holter) RecorderDatrix20031—
+2K112601Intricon Datrix Sirona Event/ Holter RecorderIntricon Datrix Corporation20110—
+2K062959DMS 300-2, 300-3 and 300-4Diagnostic Monitoring Software20061—
+3K133014DMS 300-2W Holter Ecg RecorderDiagnostic Monitoring Software20140—