510(k) Report

Devices descending from K202334

4 later devices reach Neuronaute through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231366Neuronaute PlusBioserenity Sas20231—
+1K223644Neuronaute with IceCap 2 & IceCap 2 SmallBioserenity20231—
+2K261101Ceribell MonitorCeribell, Inc.20260—
+2K243788IceCap product lineBioserenity Medical Devices Group20250—