510(k) Report

Devices descending from K931968

16 later devices reach Cdi 100 Extracorporeal Hematocrit/Oxygen Saturatio through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071725M2 MonitorSpectrum Medical, Ltd.200714—
+1K062468Spectrum M2 MonitorSpectrum Medical, Llp200615—
+2K163657Quantum WorkstationSpectrum Medical, Ltd.20172—
+2K072131M3 MonitorSpectrum Medical, Ltd.200710—
+3K181923Quantum Workstation 12.1Spectrum Medical, Ltd.20181—
+3K091908M3 MonitorSpectrum Medical, Ltd.200951
+3K090147Blood Monitoring Unit, Model Bmu 40Maquet Cardiopulmonary, AG200931
+4K202557Quantum Workstation 12 EliteSpectrum Medical, Ltd.20200—
+4K110957M4 MonitorSpectrum Medical, Llp20114—
+4K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+5K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical, Ltd.20183—
+5K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+5K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—
+6K181942Quantum Ventilation ModuleSpectrum Medical, Ltd.20182—
+7K202733Quantum Ventilation ModuleSpectrum Medical, Ltd.20201—
+8K210669Quantum Mini Ventilation ModuleSpectrum Medical, Ltd.20210—