510(k) Report

Devices descending from K090277

8 later devices reach Natus Sleepworks, Model 104017 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173366NicoletOneNatus Neurology Incorporated20183—
+1K163617REMbrandtEmbla Systems20170—
+1K162140RemLogicEmbla Systems20160—
+1K153353Sandman EliteEmbla Systems20161—
+2K200878Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20201—
+2K190760Cadwell Bolt SoftwareCadwell Industries, Inc.20190—
+2K182227Esprit NovaNeurozone Msh Incorporated20190—
+3K251881HippoMind (v1.0)Hippoclinic20250—