510(k) Report

Devices descending from K013565

3 later devices reach Cardiac Diagnostic System, Model CH2000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022149Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc.20022—
+2K050225Heartwave II Cardiac Diagnostic SystemCambridge Heart, Inc.20051—
+3K100362Cambridge Heart OemCambridge Heart, Inc.20100—