510(k) Report

Devices descending from K012206

6 later devices reach Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013565Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc.20013—
+1K013564Modification to Heartwave Alternans Processing System, Model ApsCambridge Heart, Inc.20011—
+2K022152Heartwave Alternans Processing System, Model ApsCambridge Heart, Inc.20020—
+2K022149Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc.20022—
+3K050225Heartwave II Cardiac Diagnostic SystemCambridge Heart, Inc.20051—
+4K100362Cambridge Heart OemCambridge Heart, Inc.20100—