510(k) Report

Devices descending from K921068

7 later devices reach Gikter Ecg Cassette Tape Recorder Model XR 300 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982975Digital Ecg Holter Recorder, Model DR512Datrix19985—
+1K970298DM-400 Holter Ecg Cassette RecorderDiagnostic Monitoring19970—
+2K062007DMS 300-7Diagnostic Monitoring Software20062—
+2K031074Digital Ambulatory Ecg (Holter) RecorderDatrix20031—
+3K112601Intricon Datrix Sirona Event/ Holter RecorderIntricon Datrix Corporation20110—
+3K062959DMS 300-2, 300-3 and 300-4Diagnostic Monitoring Software20061—
+4K133014DMS 300-2W Holter Ecg RecorderDiagnostic Monitoring Software20140—