510(k) Report

Devices descending from K081437

5 later devices reach Mac 1600 Ecg Analysis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090212Mac 800 Resting Ecg Analysis SystemGe Medical Syst. Information Technologies200941
+2K142288MAC 800 Resting ECG Analysis SystemGe Medical Systems China Co., Ltd.20140—
+2K140020Hyperq Acs-100 SystemBsp-Biiological Signal Processing, Ltd.20140—
+2K133622Mac 2000 Ecg Analysis SystemWipro GE Healthcare20141—
+3K230834CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800HTrismed Co., Ltd.20230—