510(k) Report

Devices descending from K050835

7 later devices reach Datex-Ohmeda S/5TM Entropy Module, E-Entropy and Accessories through their predicates, nearest generation first.

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