510(k) Report

Devices descending from K041670

7 later devices reach Bis Pediatric Sensor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151576Neon EEGIncereb, Ltd.20151—
+1K143506Bis Standard Sensor,1-Channel (3 Electrodes); Bis Pedi Sensor,1-Channel,3 Electrodes…Covidien20154—
+2K243788IceCap product lineBioserenity Medical Devices Group20250—
+2K241160CAIs Sensor (CAIs-001)Brainu Co., Ltd.20240—
+2K222671DeltaScan PatchProlira B.V.20230—
+2K220448Disposable Non-invasive EEG SensorShenzhen Med-Link Electronics Tech Co., Ltd.20231—
+3K240668Amydi-med Disposable Non-invasive EEG electrodesShenzhen Amydi-Med Electrics Tech Co., Ltd.20240—