510(k) Report

Devices descending from K002734

21 later devices reach Aspect Medical Sytems Eeg Enhanced Bis Sensor 186-0106 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093183Bis Quatro SensorAspect Medical Systems, Inc.20095—
+1K091854Bis Click Sensor/CableAspect Medical Systems, Inc.20090—
+1K062692Bis Bilateral SensorAspect Medical Systems, Inc.200671
+1K050313Bis SRS (Semi-Resuable Sensor)Aspect Medical Systems, Inc.20051—
+1K041670Bis Pediatric SensorAspect Medical Systems, Inc.20047—
+1K013389Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesDatex-Ohmeda200210—
+2K151576Neon EEGIncereb, Ltd.20151—
+2K143506Bis Standard Sensor,1-Channel (3 Electrodes); Bis Pedi Sensor,1-Channel,3 Electrodes…Covidien20154—
+2K052145Datex-Ohmeda S/5 Bis Module, E-Bis and AccessoriesGE Healthcare20050—
+2K023459Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesDatex-Ohmeda20038—
+3K243788IceCap product lineBioserenity Medical Devices Group20250—
+3K241160CAIs Sensor (CAIs-001)Brainu Co., Ltd.20240—
+3K222671DeltaScan PatchProlira B.V.20230—
+3K220448Disposable Non-invasive EEG SensorShenzhen Med-Link Electronics Tech Co., Ltd.20231—
+3K062580GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784)GE Healthcare20074—
+3K050835Datex-Ohmeda S/5TM Entropy Module, E-Entropy and AccessoriesGE Healthcare20057—
+4K240668Amydi-med Disposable Non-invasive EEG electrodesShenzhen Amydi-Med Electrics Tech Co., Ltd.20240—
+4K082540GE Entropy SensorGE Healthcare20081—
+4K061907Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and AccessoriesGE Healthcare20082—
+5K150298Entropy Module, E-ENTROPY-01Ge Healthcare Filand OY20150—
+5K103129Entropy Easyfit SensorGE Healthcare20110—