510(k) Report

Devices descending from K962928

39 later devices reach Combined Intracranial Pressure-Temperature Sensing System (Icp/) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121573Integra Camino Icp MonitorIntrgra Lifesciences Corporation201243
+1K121159Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Intrgra Camino…Integra Lifescience Corportation20122—
+1K120252Raumedic-Icp-Temp-Monitoring-SystemRaumedic AG20125—
+1K102875Camino 110-4B Olm Intracranial Pressure Mnitoring Kit; Camino 110-4G Post Craniotomy…Integra LifeSciences Corporation201023
+1K101133Sensometrics SoftwareDpcom AS20100—
+1K072379MPS Oxiport and MPS Oxiport PlusInnerspace, Inc.20082—
+1K031086Camino Single Parameter Monitor, Model SPM-1Integra Neurosciences20030—
+1K003759Aesculap Spiegelberg Brain Pressure MonitorAesculap, Inc.200111
+1K980380Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+ Multiparameter…Diametrics Medical, Ltd.199927—
+2K250285Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003)…Raumedic AG20250—
+2K171666MPR2 logO DATALOGGERRaumedic AG20170—
+2K162108Pressio 2 ICP Monitoring SystemSophysa SA201713
+2K161010HICP200 Patient/Monitor Interconnect CableInnerspace Neuro Solutions, Inc.20160—
+2K133754Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Flex AdapterIntegra LifeSciences Corporation20140—
+2K130529Raumedic-Pto-Monitoring-SystemRaumedic AG20134—
+2K131184Integra Licox PTO2 MonitorIntegra Lifesciences Corp.201305
+2K083378SynergyInnerspace, Inc.20091—
+2K050702Neurosystems 1TM MonitorNeurosystems, LLC200517—
+2K020285Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB20023—
+3K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysa20260—
+3K071984Modification to Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB20081—
+3K061640Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation200615—
+3K060554Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB20062—
+4K102077Modification to Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB20110—
+4K080217Component Neuromonitoring SystemMoberg Research, Inc.2008141
+5K200878Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20201—
+5K191868iCEWav Neuromonitoring PlatformIce Neurosystems, Inc.20200—
+5K192572CNS EnvisionMoberg Research, Inc.20190—
+5K173366NicoletOneNatus Neurology Incorporated20183—
+5K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc.20107—
+6K251881HippoMind (v1.0)Hippoclinic20250—
+6K190760Cadwell Bolt SoftwareCadwell Industries, Inc.20190—
+6K152301Background Pattern Classification [BPc (TM)]Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20160—
+6K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc.20125—
+7K213299Wireless EEG SystemPascall Systems, Inc.20222—
+7K163644Nihon Kohden QP-160AK EEG Trend ProgramNihon Kohden Corporation20170—
+7K130238Nihon Kohden AE-918P Neuro UnitNihon Kohden Corp.20150—
+8K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.20260—
+8K240593VEEGix EEG SystemNeuroServo, Inc.20240—