Anesthesiology
Review Panel
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- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
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- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- GXWEchoencephalograph2Product Code
- GXXBlock, Test, Ultrasonic Scanner Calibration1Product Code
- GXYElectrode, Cutaneous2Product Code
- GXZElectrode, Needle2Product Code
- GYATester, Electrode/Lead, Electroencephalograph1Product Code
- GXSMonitor, Alpha2Product Code
- GWEStimulator, Photic, Evoked Response2Product Code
- GWFStimulator, Electrical, Evoked Response2Product Code
- GWGEndoscope, Neurological2Product Code
- GWIDiscriminator, Two-Point1Product Code
- GWJStimulator, Auditory, Evoked Response2Product Code
- GWKConditioner, Signal, Physiological2Product Code
- GWLAmplifier, Physiological Signal2Product Code
- GWMDevice, Monitoring, Intracranial Pressure2Product Code
- K250285NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL2Cleared 510(K)
- K240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)2Cleared 510(K)
- K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)2Cleared 510(K)
- K201989B4C System2Cleared 510(K)
- K210993CereLink ICP Monitor2Cleared 510(K)
- K201118Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level2Cleared 510(K)
- K200630Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags2Cleared 510(K)
- K200456Becker External Drainage and Monitoring System2Cleared 510(K)
- K182073BcSs-PICNI-2000 Sensor2Cleared 510(K)
- K183406CereLink ICP Monitor, CereLink ICP Extension Cable2Cleared 510(K)
- K172209AURA ICP MONITORING SYSTEM2Cleared 510(K)
- K173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit2Cleared 510(K)
- K171666MPR2 logO DATALOGGER2Cleared 510(K)
- K162108Pressio 2 ICP Monitoring System2Cleared 510(K)
- K161010HICP200 Patient/Monitor Interconnect Cable2Cleared 510(K)
- K153347Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit2Cleared 510(K)
- K152670DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables2Cleared 510(K)
- K141869QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT2Cleared 510(K)
- K133754INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER2Cleared 510(K)
- K130529RAUMEDIC-PTO-MONITORING-SYSTEM2Cleared 510(K)
- K131184INTEGRA LICOX PTO2 MONITOR2Cleared 510(K)
- K121573INTEGRA CAMINO ICP MONITOR2Cleared 510(K)
- K121159INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER2Cleared 510(K)
- K113088HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)2Cleared 510(K)
- K120252RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM2Cleared 510(K)
- K112017RAUMEDIC ICP MONITORING SYSTEM2Cleared 510(K)
- K103206RAUMEDIC- ICP-MONITORING SYSTEM2Cleared 510(K)
- K102077MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM2Cleared 510(K)
- K102875CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C2Cleared 510(K)
- K101133SENSOMETRICS SOFTWARE2Cleared 510(K)
- K083378SYNERGY2Cleared 510(K)
- K071984MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM2Cleared 510(K)
- K072379MPS OXIPORT AND MPS OXIPORT PLUS2Cleared 510(K)
- K071505MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K062584PRESSIO ICP MONITORING SYSTEM2Cleared 510(K)
- K061640INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM2Cleared 510(K)
- K053244LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT2Cleared 510(K)
- K060554CMA CEREBRAL TISSUE MONITORING SYSTEM2Cleared 510(K)
- K051599NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT2Cleared 510(K)
- K050702NEUROSYSTEMS 1TM MONITOR2Cleared 510(K)
- K050720NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-1002Cleared 510(K)
- K041838MPS (OR MPS-T)2Cleared 510(K)
- K042728CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM2Cleared 510(K)
- K040235LICOX PMO BRAIN MONITORING SYSTEM2Cleared 510(K)
- K032337HEMEDEX CRANIAL BOLT MODELS, 3601, 36022Cleared 510(K)
- K031086CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-12Cleared 510(K)
- K022638NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT2Cleared 510(K)
- K020285CMA CEREBRAL TISSUE MONITORING SYSTEM2Cleared 510(K)
- K013705ACT III VENTRICULAR CATHETER2Cleared 510(K)
- K022553CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L2Cleared 510(K)
- K020780TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP2Cleared 510(K)
- K020558LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE2Cleared 510(K)
- K013930NEUROSENSOR2Cleared 510(K)
- K010422ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER2Cleared 510(K)
- K003759AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR2Cleared 510(K)
- K003905ACTI-ICP MONITORING SYSTEM2Cleared 510(K)
- K002765LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE2Cleared 510(K)
- K002392VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V2Cleared 510(K)
- K992591CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS2Cleared 510(K)
- K980380NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS2Cleared 510(K)
- K991222CODMAN MICROSENSOR VENTRICULAR CATHETER KIT2Cleared 510(K)
- K983799MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL2Cleared 510(K)
- K982702VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD2Cleared 510(K)
- K981846PARENCHYMAL BOLT PRESSURE MONITORING KIT2Cleared 510(K)
- K974088CODMAN INTRACRANIAL BOLT2Cleared 510(K)
- K962928COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)2Cleared 510(K)
- K945585COMAN(R) CU-11 MODEL NUMBER 82-66342Cleared 510(K)
- K931609CHARTR ENG SYSTEM2Cleared 510(K)
- K940648CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER2Cleared 510(K)
- K943987OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE2Cleared 510(K)
- K914479MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER2Cleared 510(K)
- K930221CAMINO VENTRICULAR TRANSDUCER ACCESSORY2Cleared 510(K)
- K912139MODEL 7042Cleared 510(K)
- K914735VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM2Cleared 510(K)
- K884823TRANSPAC(R) II, DISPOSABLE TRANSDUCER2Cleared 510(K)
- K896834MODEL BT-1 FOT BOLT INSTALLATION KIT2Cleared 510(K)
- K893395MINI-MONITOR J7000 ICP2Cleared 510(K)
- K890468MODEL FT-100 INTRACRANIAL PRESSURE MONITOR2Cleared 510(K)
- K883881MODIFIED MODEL 2001 FIBER OPTICS CATHETER2Cleared 510(K)
- K883518EVENT MARKER & A SECOND PRESSURE TREND OUTPUT2Cleared 510(K)
- K882552METATECH ROBINSON BOLT ACCESSORY2Cleared 510(K)
- K883115PMT SUBARACHNOID SCREW, MODEL NO.1350-22Cleared 510(K)
- K882286EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET2Cleared 510(K)
- K881183VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H2Cleared 510(K)
- K880154METATECH INTRACRANIAL PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K862820LADD/STERITEK ICP MONITOR, CAT. NO. P30002Cleared 510(K)
- K863479MODIFIED ICT/B INTRACRANIAL PRESS. TRANS. EPIDURAL2Cleared 510(K)
- K853770CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT2Cleared 510(K)
- K862012LADD MEDICAL S-20002Cleared 510(K)
- K853864INTRACRANIAL PRESSURE MONITORING KIT 0702Cleared 510(K)
- K854657INTRACRANIAL PRESSURE MONITORING CUP CATHETERS2Cleared 510(K)
- K844566ICP MONITOR MODEL 10002Cleared 510(K)
- K840999PHILLY INFANT BOLT2Cleared 510(K)
- K840003DISPOSABLE ICP KIT DIFF. SIZES2Cleared 510(K)
- K822864INTRACRANIAL PRESSURE MONITORING DEVICE2Cleared 510(K)
- K822636CLASS II DEVICE FOR I.C.P. MONITORING2Cleared 510(K)
- K813440PHILLY BOLT2Cleared 510(K)
- K802149TM-5 INTRACRANIAL PRESSURE MONITOR2Cleared 510(K)
- K802137CHEEK EPIDURAL SCREW2Cleared 510(K)
- K802138CHEEK TOOL SET2Cleared 510(K)
- K802100INTRACRANIAL PRESSURING MONITORING SYST.2Cleared 510(K)
- K801755MMI/GAELTEC CATHETER TIP PRESSURE2Cleared 510(K)
- K790920INTRACRANIAL PRESSURE MONITORING2Cleared 510(K)
- K772063CATHETER, INTRACRANIAL PRESS. MONITOR.2Cleared 510(K)
- GWNNystagmograph2Product Code
- GWQFull-Montage Standard Electroencephalograph2Product Code
- GWRGenerator, Electroencephalograph Test Signal1Product Code
- GWSAnalyzer, Spectrum, Electroencephalogram Signal1Product Code
- GWWAtaxiagraph1Product Code
- GWXFork, Tuning1Product Code
- GWYPinwheel1Product Code
- GWZPercussor1Product Code
- GXBEsthesiometer1Product Code
- GYBMedia, Electroconductive2Product Code
- GYCElectrode, Cortical2Product Code
- GYDTransducer, Tremor2Product Code
- GYEEncephalogram Telemetry System2Product Code
- GZKElectrode, Nasopharyngeal2Product Code
- GZLElectrode, Depth2Product Code
- GZMAnalyzer, Rigidity2Product Code
- GZNRheoencephalograph3Product Code
- GZODevice, Galvanic Skin Response Measurement2Product Code
- GZPStimulator, Mechanical, Evoked Response2Product Code
- HCJDevice, Skin Potential Measurement2Product Code
- HCSDevice, Temperature Measurement, Direct Contact, Powered2Product Code
- JXEDevice, Nerve Conduction Velocity Measurement2Product Code
- JXFPlethysmograph, Ocular3Product Code
- LLNDevice, Vibration Threshold Measurement1Product Code
- LQWTest, Temperature Discrimination1Product Code
- NCGNeuropsychiatric Interpretative Electroencephalograph Assessment Aid2Product Code
- NTUEvoked Potential Stimulator, Thermal2Product Code
- OLTNon-Normalizing Quantitative Electroencephalograph Software2Product Code
- OLUNormalizing Quantitative Electroencephalograph Software2Product Code
- OLVStandard Polysomnograph With Electroencephalograph2Product Code
- OLWIndex-Generating Electroencephalograph Software2Product Code
- OLXSource Localization Software For Electroencephalograph Or Magnetoencephalograph2Product Code
- OLYMagnetoencephalograph2Product Code
- OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph2Product Code
- OMAAmplitude-Integrated Electroencephalograph2Product Code
- OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph2Product Code
- OMCReduced- Montage Standard Electroencephalograph2Product Code
- ORTBurst Suppression Detection Software For Electroencephalograph2Product Code
- PIWBrain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid2Product Code
- PKQComputerized Cognitive Assessment Aid2Product Code
- PNAEvoked Photon Image Capture Device1Product Code
- POMComputerized Cognitive Assessment Aid For Concussion2Product Code
- POPCranial Motion Measurement Device2Product Code
- POSPhysiological Signal Based Seizure Monitoring System2Product Code
- PSPIntracranial Pressure & Temperature Monitoring Kit2Product Code
- PTBAtaxiagraph With Interpretive Software1Product Code
- PTYComputerized Cognitive Assessment Aid, Exempt2Product Code
- PVPNeurological Test Kit1Product Code
- QEABrain Injury Adjunctive Interpretive Oculomotor Assessment Aid2Product Code
- QPFPediatric Autism Spectrum Disorder Diagnosis Aid2Product Code
- OPTInfrared Hematoma Detector2Product Code
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Pressio 2 ICP Monitoring System
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K162108
- 510(k) Type
- Traditional
- Applicant
- Sophysa SA
- Country
- France
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/17/2017
- Days to Decision
- 262 days
- Submission Type
- Summary