510(k) Report

Devices descending from K073625

7 later devices reach Modification to: Mac 5500 Resting Ecg Analysis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133622Mac 2000 Ecg Analysis SystemWipro GE Healthcare20141—
+1K103765Mac 600 Resting Ecg Analysis SystemGe Medical Systems Information Technologies, Inc.20110—
+1K110266Mac 5500 HD, Mac 3500Ge Medical Systems Information Technologies, Inc.20111—
+1K093172Quantitative Electrocardiographic Detector (Qed 1000)Dynacardia, Inc.20100—
+1K092663Eli 350 ElectrocardiographMortara Instrument, Inc.200901
+2K230834CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800HTrismed Co., Ltd.20230—
+2K152135Quantitative Electrocardiographic Detector (QED 2000)Acme Portable Machines, Inc.20160—