510(k) Report

Devices descending from K100683

6 later devices reach Neurolink IP Model: PK1117 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143440Natus QuantumNatus Medical Incorporated201541
+1K111055Galaxy System; JupiterPersonal Health Institute International20110—
+2K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+2K180290Natus Brain Monitor AmplifierNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)201811
+2K180181Natus QuantumNatus Medical Incorporated Dba Excel_Tech Ltd. (Xltek)20181—
+3K193159NeuroAmp II, NeuroAmp II.5sCorscience GmbH & Co. KG20200—