510(k) Report

Devices descending from K050004

5 later devices reach Philips Heartstart FRX Defibrillator, Model 861304 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120350Extended Life BatteryAed Battery Exchange, LLC20120—
+1K091548Amco Replacement Battery for Philips Medical Models BT1 and M5070AAmco International Manufacturing & Design, Inc.20090—
+1K072812Philips Heartstart Smartpads IiiPhilips Medical Systems20083—
+2K111693Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems201121
+3K130684Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems201301