510(k) Report

Devices descending from K061707

4 later devices reach Heartstart MRX, Invasive Pressure & Temperature Options through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems20132—
+1K063375Heartstart MRX, Models M3535A or M3536APhilips Medical Systems2007011
+2K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+3K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004