510(k) Report

Devices descending from K101046

3 later devices reach Stockert S5 System and Gas Blender and Sorin C5 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181942Quantum Ventilation ModuleSpectrum Medical, Ltd.20182—
+2K202733Quantum Ventilation ModuleSpectrum Medical, Ltd.20201—
+3K210669Quantum Mini Ventilation ModuleSpectrum Medical, Ltd.20210—