510(k) Report

Devices descending from K071725

14 later devices reach M2 Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163657Quantum WorkstationSpectrum Medical, Ltd.20172—
+1K072131M3 MonitorSpectrum Medical, Ltd.200710—
+2K181923Quantum Workstation 12.1Spectrum Medical, Ltd.20181—
+2K091908M3 MonitorSpectrum Medical, Ltd.200951
+2K090147Blood Monitoring Unit, Model Bmu 40Maquet Cardiopulmonary, AG200931
+3K202557Quantum Workstation 12 EliteSpectrum Medical, Ltd.20200—
+3K110957M4 MonitorSpectrum Medical, Llp20114—
+3K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+4K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical, Ltd.20183—
+4K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+4K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—
+5K181942Quantum Ventilation ModuleSpectrum Medical, Ltd.20182—
+6K202733Quantum Ventilation ModuleSpectrum Medical, Ltd.20201—
+7K210669Quantum Mini Ventilation ModuleSpectrum Medical, Ltd.20210—