510(k) Report

Devices descending from K012414

3 later devices reach Prime Ecg System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082312Prime Ecg System (with Enhanced Diagnostic Algorithm)Heartscape Technologies, Ltd.20080—
+1K042088Samaritan Pad Pak Defibrillation Electrode, Model SPP-301Heartsine Technologies, Inc.20040—
+1K030104Prime Ecg SystemMeridian Medical Technologies, Inc.20031—