510(k) Report

Devices descending from K761301

14 later devices reach V-Trace Ecg Backpad through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K961821Aspect Medical Systems Zipprep Eeg SensorAspect Medical Systems, Inc.199613—
+2K070069Zipprep ElectrodeAspect Medical Systems, Inc.20070—
+2K994330Aspect Medical Systems Eeg Sensor, Model 186-0076Aspect Medical Systems, Inc.200011—
+3K013389Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesDatex-Ohmeda200210—
+4K052145Datex-Ohmeda S/5 Bis Module, E-Bis and AccessoriesGE Healthcare20050—
+4K023459Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesDatex-Ohmeda20038—
+5K062580GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784)GE Healthcare20074—
+5K050835Datex-Ohmeda S/5TM Entropy Module, E-Entropy and AccessoriesGE Healthcare20057—
+6K220448Disposable Non-invasive EEG SensorShenzhen Med-Link Electronics Tech Co., Ltd.20231—
+6K082540GE Entropy SensorGE Healthcare20081—
+6K061907Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and AccessoriesGE Healthcare20082—
+7K240668Amydi-med Disposable Non-invasive EEG electrodesShenzhen Amydi-Med Electrics Tech Co., Ltd.20240—
+7K150298Entropy Module, E-ENTROPY-01Ge Healthcare Filand OY20150—
+7K103129Entropy Easyfit SensorGE Healthcare20110—