510(k) Report

Devices descending from K011865

5 later devices reach Zoll M Series Ibp Operation; Zoll M Series Temperature Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061707Heartstart MRX, Invasive Pressure & Temperature OptionsPhilips Medical Systems20064Class I
+2K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems20132—
+2K063375Heartstart MRX, Models M3535A or M3536APhilips Medical Systems2007011
+3K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+4K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004