510(k) Report

Devices descending from K143506

4 later devices reach Bis Standard Sensor,1-Channel (3 Electrodes); Bis Pedi Sensor,1-Channel,3… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241160CAIs Sensor (CAIs-001)Brainu Co., Ltd.20240—
+1K222671DeltaScan PatchProlira B.V.20230—
+1K220448Disposable Non-invasive EEG SensorShenzhen Med-Link Electronics Tech Co., Ltd.20231—
+2K240668Amydi-med Disposable Non-invasive EEG electrodesShenzhen Amydi-Med Electrics Tech Co., Ltd.20240—