510(k) Report

Devices descending from K951832

26 later devices reach Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013376Qflow 500 Perfusion Monitoring SystemHemedex Incorporated20020—
+1K962700Ventricular Catheter Blood Flow Monitoring Probe Kit and Ventraflo Blood Flow Monitoring…Vasamedics, LLC19971—
+1K961368Trimflo Parenchymal Blood Flow Monitoring Probe KitVasamedics, LLC199624—
+2K013930NeurosensorNovus Monitoring, Ltd.200222—
+3K050702Neurosystems 1TM MonitorNeurosystems, LLC200517—
+3K050720Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit/System, Models…Integra Neurosciences200511
+3K042728Camino Slim-Line Intracranial Monitoring SystemNovus Monitoring, Ltd.20041—
+4K172209Aura Icp Monitoring SystemBranchpoint Technologies, Inc.20180—
+4K101133Sensometrics SoftwareDpcom AS20100—
+4K071505Modification to Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring…Integra LifeSciences Corporation200701
+4K061640Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation200615—
+5K080217Component Neuromonitoring SystemMoberg Research, Inc.2008141
+6K200878Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20201—
+6K191868iCEWav Neuromonitoring PlatformIce Neurosystems, Inc.20200—
+6K192572CNS EnvisionMoberg Research, Inc.20190—
+6K173366NicoletOneNatus Neurology Incorporated20183—
+6K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc.20107—
+7K251881HippoMind (v1.0)Hippoclinic20250—
+7K190760Cadwell Bolt SoftwareCadwell Industries, Inc.20190—
+7K152301Background Pattern Classification [BPc (TM)]Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20160—
+7K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc.20125—
+8K213299Wireless EEG SystemPascall Systems, Inc.20222—
+8K163644Nihon Kohden QP-160AK EEG Trend ProgramNihon Kohden Corporation20170—
+8K130238Nihon Kohden AE-918P Neuro UnitNihon Kohden Corp.20150—
+9K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.20260—
+9K240593VEEGix EEG SystemNeuroServo, Inc.20240—