510(k) Report

Devices descending from K003565

10 later devices reach Heartstream FR2 Aed, Model M3860A,M3861A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111693Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems201121
+1K040904Philips Heartstart Home Defibrillator, Model M5068APhilips Medical Systems200427
+1K023854Samaritan Aed, Model Sam-01Heartsine Technologies, Inc.200331
+1K020984Accessaed, Semi-Automatic External DefibrillatorsAccess Cardiosystems, Inc.200202
+2K130684Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems201301
+2K120350Extended Life BatteryAed Battery Exchange, LLC20120—
+2K091548Amco Replacement Battery for Philips Medical Models BT1 and M5070AAmco International Manufacturing & Design, Inc.20090—
+2K041067Heartsine Samaritan PadHeartsine Technologies, Inc.20042Class I
+3K123881Heartsine Samaritan Pad 350PHeartsine Technologies, Inc.201311
+4K142709samaritan PAD 450PHeartsine Technologies, Inc.20150—