510(k) Report

Devices descending from K014157

9 later devices reach HEARTSTREAMFR2 Aed with M3848A and M3849A, Models M3860A, M3861, M3840A, M3841A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130684Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems201301
+1K111693Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems201121
+1K042404Lifepak, Model 1000Medtronic Emergency Response Systems, Inc.200512
+1K040637Powerheart Aed G3 ProCardiac Science, Inc.200438
+2K120350Extended Life BatteryAed Battery Exchange, LLC20120—
+2K122600Lifepak 1000 DefibrillatorPhysio-Control, Inc.20120Class I
+2K102496Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed G3 Pro…Cardiac Science Corporation201122
+3K122758Powerheart G5 AedCardiac Science Corporation20141—
+4K143714Powerheart G5 AEDCardiac Science Corporation20150—