510(k) Report

Devices descending from K130153

2 later devices reach Hearstart MRX with Airway Confimration Assist through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+2K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004