510(k) Report

Devices descending from K983102

9 later devices reach Cardiac Diagnostic System Model CH 2000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013615Micro-Induction 1000 SystemHarbinger Medical, Inc.20021—
+1K012206Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave Alternans…Cambridge Heart, Inc.20016—
+2K090249Modification to: Micro-Induction 1000 SystemHarbinger Medical, Inc.20090—
+2K013565Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc.20013—
+2K013564Modification to Heartwave Alternans Processing System, Model ApsCambridge Heart, Inc.20011—
+3K022152Heartwave Alternans Processing System, Model ApsCambridge Heart, Inc.20020—
+3K022149Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc.20022—
+4K050225Heartwave II Cardiac Diagnostic SystemCambridge Heart, Inc.20051—
+5K100362Cambridge Heart OemCambridge Heart, Inc.20100—