510(k) Report

Devices descending from K013389

10 later devices reach Datex-Ohmeda S/5 Bis Module, M-Bis and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052145Datex-Ohmeda S/5 Bis Module, E-Bis and AccessoriesGE Healthcare20050—
+1K023459Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesDatex-Ohmeda20038—
+2K062580GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784)GE Healthcare20074—
+2K050835Datex-Ohmeda S/5TM Entropy Module, E-Entropy and AccessoriesGE Healthcare20057—
+3K220448Disposable Non-invasive EEG SensorShenzhen Med-Link Electronics Tech Co., Ltd.20231—
+3K082540GE Entropy SensorGE Healthcare20081—
+3K061907Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and AccessoriesGE Healthcare20082—
+4K240668Amydi-med Disposable Non-invasive EEG electrodesShenzhen Amydi-Med Electrics Tech Co., Ltd.20240—
+4K150298Entropy Module, E-ENTROPY-01Ge Healthcare Filand OY20150—
+4K103129Entropy Easyfit SensorGE Healthcare20110—