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- 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
- GWNNystagmograph2Product Code
- GWQFull-Montage Standard Electroencephalograph2Product Code
- K233403Flexset System2Cleared 510(K)
- K231366Neuronaute Plus2Cleared 510(K)
- K221959Q212Cleared 510(K)
- K231457SPARK Scan2Cleared 510(K)
- K221963Cumulus Functional Neurophysiology Platform2Cleared 510(K)
- K230073Okti2Cleared 510(K)
- K223644Neuronaute with IceCap 2 & IceCap 2 Small2Cleared 510(K)
- K220056iSyncWave2Cleared 510(K)
- K212788Seer Home2Cleared 510(K)
- K213900WAVi SCAN EEG System and Accessories2Cleared 510(K)
- K193159NeuroAmp II, NeuroAmp II.5s2Cleared 510(K)
- K202334Neuronaute2Cleared 510(K)
- K201819Cadwell Apollo System2Cleared 510(K)
- K191492Maxxi Position Sensor2Cleared 510(K)
- K191868iCEWav Neuromonitoring Platform2Cleared 510(K)
- K192753NeuralScan System2Cleared 510(K)
- K181466Cadwell Zenith System2Cleared 510(K)
- K180269Cadwell Apollo System2Cleared 510(K)
- K180290Natus Brain Monitor Amplifier2Cleared 510(K)
- K172271Trackit T4 EEG Amplifier2Cleared 510(K)
- K172735WR19 System2Cleared 510(K)
- K180181Natus Quantum2Cleared 510(K)
- K173460NeuroEEG2Cleared 510(K)
- K171384Micromed BRAIN QUICK system2Cleared 510(K)
- K170138NEURONAUTE2Cleared 510(K)
- K171781eVox System2Cleared 510(K)
- K171124Nihon Kohden Wireless Input Unit WEE-12002Cleared 510(K)
- K170441ElectroTek2Cleared 510(K)
- K162681Enobio Wireless EEG2Cleared 510(K)
- K163163XLTEK EMU40EX EEG Headbox2Cleared 510(K)
- K162595Trex_HD2Cleared 510(K)
- K150498Discovery 242Cleared 510(K)
- K143233Mitsar-EEG2Cleared 510(K)
- K143440Natus Quantum2Cleared 510(K)
- K131335BWMINI EEG, BWMINIHST, BWMINI PSG2Cleared 510(K)
- K131266TREZ_HD2Cleared 510(K)
- K133355CADWELL FLEX EEG/PSG2Cleared 510(K)
- K131383X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE2Cleared 510(K)
- K122196CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY2Cleared 510(K)
- K120888PSG-1100 SLEEP DIAGNOSTIC SYSTEM2Cleared 510(K)
- K112817MICROEEG SYSTEM2Cleared 510(K)
- K113117NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX2Cleared 510(K)
- K112353GEODESIC EEG MOBILE 100 (GEM 100)2Cleared 510(K)
- K112107BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS2Cleared 510(K)
- K083577HARMONIE SYSTEM2Cleared 510(K)
- K110376PE-210AK SWITCH BOX2Cleared 510(K)
- K103129ENTROPY EASYFIT SENSOR2Cleared 510(K)
- K101386VIGILANT EEG MONITOR MODEL VIGILANT 2.02Cleared 510(K)
- K100683NEUROLINK IP MODEL: PK11172Cleared 510(K)
- K093223COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG2Cleared 510(K)
- K081741NEUROLINK IP, MODEL PK11132Cleared 510(K)
- K081151COMPUMEDICS NEUVO2Cleared 510(K)
- K071109SACS EEG WORKSTATION A72Cleared 510(K)
- K061908NICOLETONE SYSTEM V32 AMPLIFIER2Cleared 510(K)
- K053386XLTEK EMU40 EEG HEADBOX, MODEL PK10722Cleared 510(K)
- K051825COGNITRACE2Cleared 510(K)
- K042626NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM2Cleared 510(K)
- K043309GEODESIC PHOTOGRAMMETRY SYSTEM2Cleared 510(K)
- K042150XLTEK TREX MODEL#103092Cleared 510(K)
- K033399GEODESIC EEG SYSTEM SERIES 1002Cleared 510(K)
- K040554ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM712562Cleared 510(K)
- K040360EMU128S, MODEL EX-NW-128S2Cleared 510(K)
- K033978ADAM2Cleared 510(K)
- K023771SYNAMPS22Cleared 510(K)
- K022785EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION2Cleared 510(K)
- K02159996 CHANNEL EEG HEADBOX MODEL EMU962Cleared 510(K)
- K01414780 CHANNEL EEG2Cleared 510(K)
- K01414684 CHANNEL EEG2Cleared 510(K)
- K010997PAM-RL2Cleared 510(K)
- K012079GEODESIC EEG SYSTEM, MODEL 2002Cleared 510(K)
- K010697UNIQUE AMBULATORY EEG2Cleared 510(K)
- K010669NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-12Cleared 510(K)
- K011430ACTIWARE-PLMS2Cleared 510(K)
- K010086REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED)2Cleared 510(K)
- K010089REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED)2Cleared 510(K)
- K010088REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED)2Cleared 510(K)
- K010084REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP2Cleared 510(K)
- K01015064 CHANNEL EEG / MODEL NUMBER EX-NW-642Cleared 510(K)
- K010091EEG WITH VIDEO, MODEL EX-NW2Cleared 510(K)
- K002316PHOENIX DIGITAL EEG2Cleared 510(K)
- K002570BIO-LOGIC CEEGRAPH NETLINK2Cleared 510(K)
- K000919128 CHANNEL EEG HEADBOX, MODEL EX-NW-1282Cleared 510(K)
- K001103WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED)2Cleared 510(K)
- K000898EEG WITH VIDEO, MODEL EX-NW2Cleared 510(K)
- K991054BRAVO MULTI-MODALITY SYSTEM2Cleared 510(K)
- K992410ACTITRAC2Cleared 510(K)
- K991033ACTIWATCH-SCORE2Cleared 510(K)
- K983533ACTIWATCH2Cleared 510(K)
- K982479EXCEL AMBULATORY EEG2Cleared 510(K)
- K980214EXCEL NEURO WORKS2Cleared 510(K)
- K973883BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEM2Cleared 510(K)
- K974495NEUROAMP EEG AMPLIFIER2Cleared 510(K)
- K971329CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM)2Cleared 510(K)
- K972202DEEG-LITE2Cleared 510(K)
- K971331SATELLITE2Cleared 510(K)
- K970942MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM2Cleared 510(K)
- K970703GALILEO HALLEY2Cleared 510(K)
- K964280DG NERVUS2Cleared 510(K)
- K961642MEDILOG MR952Cleared 510(K)
- K962447EQUINOX DIGITAL EEG SYSTEM2Cleared 510(K)
- K962157MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM2Cleared 510(K)
- K954954CEEGRAPH TRAVELER AMBULATORY EEG RECORDER2Cleared 510(K)
- K953449MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS2Cleared 510(K)
- K946094CADWELL EASY AMBULATORY EEG2Cleared 510(K)
- K951507PRINCIPLE COMPONENT EEG ANALYSIS SOFTWARE2Cleared 510(K)
- K944678NIHON KOHDEN ELECTROENCEPHALOGRAPH2Cleared 510(K)
- K941551THE VANGUARD SYSTEM2Cleared 510(K)
- K934670DG 3P SYSTEM2Cleared 510(K)
- K932407CADWELL EASY WRITER AND EASY READER2Cleared 510(K)
- K933233CEEGRAPH, MODIFICATION2Cleared 510(K)
- K932842SPACELABS MEDICAL MODEL 90481 EEG MODULE2Cleared 510(K)
- K933951VIDEO EEG OPTION MODIFICATION2Cleared 510(K)
- K930080E*NET NEUROMONITORING SYSTEM2Cleared 510(K)
- K924179EEG MODEL 24/322Cleared 510(K)
- K921138NICOLET ULTRASOM ACQUISITION STATION2Cleared 510(K)
- K925838TELEFACTOR D/EEG-322Cleared 510(K)
- K923894YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH2Cleared 510(K)
- K923860THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR2Cleared 510(K)
- K923950THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH2Cleared 510(K)
- K921927NICOLET VOYAGEUR2Cleared 510(K)
- K922548MEDELEC 2110 AND 2114 EEG2Cleared 510(K)
- K921485LA MONT VIDEO PATIENT MONITORING SYSTEM2Cleared 510(K)
- K920127ELECTROENCEPHALOGRAPH RECORDING SYSTEM2Cleared 510(K)
- K915096NEUROFAX EEG 55322Cleared 510(K)
- K914571NEUROTRAC II2Cleared 510(K)
- K910972WALTER GRAPHTEK2Cleared 510(K)
- K911229PHOENIX DIGITAL EEG SYSTEM2Cleared 510(K)
- K910279MCSEER/MICRO CONTROLLER SLD ST EEG EVENT RECORDER2Cleared 510(K)
- K910945HORIZON 2000 EEG MONITORING OPTION2Cleared 510(K)
- K905435UNIQUANT2Cleared 510(K)
- K904269NEUROSEARCH-24 OR NRS-242Cleared 510(K)
- K904763MENTOR EEG SYSTEM2Cleared 510(K)
- K902550EEG-5400 SERIES2Cleared 510(K)
- K902752NEURITOR 20012Cleared 510(K)
- K903004EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH2Cleared 510(K)
- K901549CNS SATELLITE 100, 200, 1000, 2000 ELECTROENCE.2Cleared 510(K)
- K896942SPACELABS MODEL 90480 EEG MODULE2Cleared 510(K)
- K896666P460, DG32 ELECTROENCEPHALOGRAPH2Cleared 510(K)
- K895125CEEGRAPH2Cleared 510(K)
- K894044ACTILLUME2Cleared 510(K)
- K894276CADWELL FREEDOM EEG DEVICE2Cleared 510(K)
- K890881TECA 1A96, 1A97 AND 1A98 ELECTROENCEPHALOGRAPHS2Cleared 510(K)
- K884537AE-800PA EEG MODULE2Cleared 510(K)
- K883557NEUROWAVE SYSTEM 22Cleared 510(K)
- K870815KONTRON E.E.G. MONITOR, SUPERMON MODULE 72652Cleared 510(K)
- K874796MODEL EEG 4400 WITH OPTIONAL ACCESSORIES2Cleared 510(K)
- K873535NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM2Cleared 510(K)
- K872183AMBULATORY EEG PLAYBACK2Cleared 510(K)
- K871500MODEL 5000 AMBULATORY MONITORING SYSTEM2Cleared 510(K)
- K870432A1-A2 AMBULATORY EEG CASSETTE RECORDER2Cleared 510(K)
- K870263NEUROMAPPER 16202Cleared 510(K)
- K864928BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER2Cleared 510(K)
- K863193SENTINEL 4 EEG ANALYZER2Cleared 510(K)
- K863124MODEL 8 EEG PREAMPLIFIER2Cleared 510(K)
- K863749TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH2Cleared 510(K)
- K854663NEUROFAX 7310 SERIES (EEG)2Cleared 510(K)
- K860456MODEL 9000 RECORDING & ELECTROPHYSIOLOGICAL SYSTEM2Cleared 510(K)
- K854030WRIST ACTIGRAPH2Cleared 510(K)
- K854268DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER2Cleared 510(K)
- K851232TECA MONTAGE II2Cleared 510(K)
- K850418BUSHEL OFF-HEAD PREAMPLIFIER2Cleared 510(K)
- K850259ELECTROENCEPHALOGRAPH EEG2Cleared 510(K)
- K842784CEREGROTRAC2Cleared 510(K)
- K841653DEL MAR AVIONICS 5509 NEURO-SCANNER2Cleared 510(K)
- K842714EEG-4300 W/OPTINAL ACCESS. EEG 4314 &2Cleared 510(K)
- K841683Q.P. PREAMPLIFIER SYS2Cleared 510(K)
- K841684BIO/SCAN BIOLOG CASSETTE RECORDER2Cleared 510(K)
- K831324EEG 42/2P ELECTRO ENCEPHALOGRAPH2Cleared 510(K)
- K830295MEDILOG 9000 SYSTEM2Cleared 510(K)
- K823140ELECTROENCEPHALOGRAPH2Cleared 510(K)
- K823116NEUROTRAC2Cleared 510(K)
- K822700DEL MAR MODEL 5500 EEG SCANNER2Cleared 510(K)
- K820779OTE BIOMEDICAL #1296 - 16 CHAN. RECORD2Cleared 510(K)
- K820605OTE BIOMEDICA NEUROGRAPH 182Cleared 510(K)
- K820604OTE BIOMEDICA NEUROGRAPH 92Cleared 510(K)
- K820603OTE BIOMEDICA NEUROGRAPH 142Cleared 510(K)
- K820066ELECTROENCEPHALOGRAPHS EEG-5208,52102Cleared 510(K)
- K802887MODEL EEG 42212Cleared 510(K)
- K802292MINGOGRAF EEG212Cleared 510(K)
- K802296MINGOGRAF EEG102Cleared 510(K)
- K791234MODEL EEG-4217 ELECTROENCEPHALOGRAPH2Cleared 510(K)
- K791233MODEL EEG-4214 ELECTROENCEPHALOGRAPH2Cleared 510(K)
- K791150ELECTROENCEPHALOGRAPHS MODELS 7209,72132Cleared 510(K)
- K781129ACCESSORY TO 4-24 RECORDER2Cleared 510(K)
- K781041ELECTROENCEPHALOGRAPH ACCUTRACE 1002Cleared 510(K)
- K781005ELECTROENCEPHALOGRAPH ACCUTRATE 2002Cleared 510(K)
- K770246ISOLATED EEG AMPLIFIER MODULE2Cleared 510(K)
- 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
GALILEO HALLEY
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K970703
- 510(k) Type
- Traditional
- Applicant
- BIOSOUND ESAOTE, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/19/1997
- Days to Decision
- 82 days
- Submission Type
- Summary