510(k) Report

Devices descending from K895379

2 later devices reach Low Energy DC - Defibrillator (Including Paddles) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsPhysio-Control, Inc.201911
+2K203231Switched Internal PaddlesPhilips North America, LLC20210—