510(k) Report

Devices descending from K993533

13 later devices reach Powerheart Aecd through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K011901Firstsave Star Biphasic, Model 9210/9200Survivalink Corp.2002112
+1K012197Powerheart Cardiac Rhythm ModuleCardiac Science, Inc.200101
+2K040438Powerheart Aed G3ACardiac Science, Inc.2004625
+2K031987Powerheart Aed G3, Model 9300Cardiac Science2003833
+2K022929Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed, Model…Cardiac Science, Inc.200310—
+3K141231ZP9141, ZP9146Y, ZP9146W Non-Rechargeable BatteryZeller Power Products (Battery Beast, LLC)20140—
+3K122758Powerheart G5 AedCardiac Science Corporation20141—
+3K120350Extended Life BatteryAed Battery Exchange, LLC20120—
+3K102496Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed G3 Pro…Cardiac Science Corporation201122
+3K082861Amco Replacement Battery for Powerheart Aed, Non-Rechargeable, Model 2L561; G3…Amco International Manufacturing & Design, Inc.20080—
+3K072430Zoll Pedipadz Reduced Energy ElectrodeZOLL Medical Corporation200701
+3K040637Powerheart Aed G3 ProCardiac Science, Inc.200438
+4K143714Powerheart G5 AEDCardiac Science Corporation20150—