510(k) Report

Devices descending from K893232

40 later devices reach Model V420 Direct Pressure Monitor & 427 Waveform through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K962928Combined Intracranial Pressure-Temperature Sensing System (Icp/)Camino Neurocare, Inc.1996392
+2K121573Integra Camino Icp MonitorIntrgra Lifesciences Corporation201243
+2K121159Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Intrgra Camino…Integra Lifescience Corportation20122—
+2K120252Raumedic-Icp-Temp-Monitoring-SystemRaumedic AG20125—
+2K102875Camino 110-4B Olm Intracranial Pressure Mnitoring Kit; Camino 110-4G Post Craniotomy…Integra LifeSciences Corporation201023
+2K101133Sensometrics SoftwareDpcom AS20100—
+2K072379MPS Oxiport and MPS Oxiport PlusInnerspace, Inc.20082—
+2K031086Camino Single Parameter Monitor, Model SPM-1Integra Neurosciences20030—
+2K003759Aesculap Spiegelberg Brain Pressure MonitorAesculap, Inc.200111
+2K980380Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+ Multiparameter…Diametrics Medical, Ltd.199927—
+3K250285Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003)…Raumedic AG20250—
+3K171666MPR2 logO DATALOGGERRaumedic AG20170—
+3K162108Pressio 2 ICP Monitoring SystemSophysa SA201713
+3K161010HICP200 Patient/Monitor Interconnect CableInnerspace Neuro Solutions, Inc.20160—
+3K133754Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Flex AdapterIntegra LifeSciences Corporation20140—
+3K130529Raumedic-Pto-Monitoring-SystemRaumedic AG20134—
+3K131184Integra Licox PTO2 MonitorIntegra Lifesciences Corp.201305
+3K083378SynergyInnerspace, Inc.20091—
+3K050702Neurosystems 1TM MonitorNeurosystems, LLC200517—
+3K020285Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB20023—
+4K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysa20260—
+4K071984Modification to Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB20081—
+4K061640Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation200615—
+4K060554Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB20062—
+5K102077Modification to Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB20110—
+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—