510(k) Report

Devices descending from K051134

13 later devices reach Heartstart MRX with Q-CPR Option, Models M3535A or M3536A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130684Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems201301
+1K123597Truecpr Coaching DevicePhysio-Control, Inc.20130—
+1K122050Cprmeter CPR Feedback DeviceLaerdal Medical A/S20125—
+1K063375Heartstart MRX, Models M3535A or M3536APhilips Medical Systems2007011
+1K062233Heartstart MRX Monitor/DefibrillatorPhilips Medical Systems North America, Inc.20060Class I
+1K061707Heartstart MRX, Invasive Pressure & Temperature OptionsPhilips Medical Systems20064Class I
+2K151702Reusable Full Silicone CoverLaerdal Medical AS20153—
+2K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems20132—
+3K173886CPRmeter 2 CPR Feedback DeviceLaerdal Medical AS20182—
+3K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+4K201581CPR BandCredo20210—
+4K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+4K183348Reusable Silicone Cover CPRmeter 2Laerdal Medical AS20180—