FDA.reportPublic FDA data

Courtney Walton

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96123303002809369Courtney Walton1N2026-01-013610 County Road 101 S Wayzata MN US 55391

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
792281378848837K994142GRASS TS3201/6401 EEG AMPLIFIER SYSTEMOLV2000-03-06
792281067522037K991903EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)GWE1999-08-04
792281692742160K982351LUNAOLT1998-07-29
792281858003920K980214EXCEL NEURO WORKSGWQ1998-04-21
792281443792002K972157EXCEL AV STIM 1000GWJ1998-01-30
792281992770578K970951GRASS BRAINWAVE SOFTWAREOLV1997-05-19
792281870271246K963669GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEMGWL1996-12-12
792281902996268K960273HARMONIE SENSAOMB1996-04-04
792282025908846K941144EXCEL EMGIKN1995-11-07
792281557344156K884937BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDINGEEG1989-04-14
792281284835501K870450SZAC-16 SEIZURE ANALYSIS COMPUTEROMB1987-04-08
792281443893522K860219SASSSY SEMI AUTOMATIC SLEEP SCORING SYSTEMOLV1986-04-17
792281927002126K242930Natus BrainWatch SystemOMC2024-11-19
792281093262451K200878Natus NeuroWorksOMB2020-05-18
792281864721404K180421Natus NeuroWorksOMB2018-03-14
792281651549779K180290Natus Brain Monitor AmplifierGWQ2018-06-14
792281018816242K180181Natus QuantumGWQ2018-02-22
792281714771299K180001Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor InfantMNR2019-09-27
792281338367226K173936Natus Photic StimulatorGWE2018-06-15
792281449421600K173793XactTrace Single Use Respiratory Effort Belt SystemMNR2019-03-01
792282018244357K173690Grass TWinOLV2018-03-09
792282068761243K172711Comet-PLUSOLV2017-11-03
792281289350569K172703Disposable Snap ElectrodeGXY2017-11-13
792281252474318K163163XLTEK EMU40EX EEG HeadboxGWQ2016-12-14
792281441410452K162595Trex_HDGWQ2016-11-04
792281204011015K152301Background Pattern Classification [BPc(TM)]OMA2016-06-03
792281502689618K143440Natus QuantumGWQ2015-04-20
792281727204023K131266TREZ_HDGWQ2014-02-14
792281489322299K123079OLYMPIC BRAINZ MONITOROMA2013-05-08
792281701291972K122516EMBLETTA MPRMNR2013-02-21
792281365148836K120260ICTAOMB2012-06-29
792282027227182K100683NEUROLINK IP MODEL: PK1117GWQ2010-04-09
792281384978814K100126STELLATE GRIDVIEWOLX2010-12-03
792281860638933K093949OLYMPIC BRAINZ MONITOR MODEL OBM70001OMA2010-06-16
792281884846856K093728BE MICRO, TREAOLV2010-04-29
792281774177225K093304PROTEKTOR 32GWF2010-08-11
792281952951354K090277NATUS SLEEPWORKS, MODEL 104017OLZ2011-04-19
792281688663618K090019NATUS NEUROWORKS, MODEL 104196OMB2010-02-22
792281858894495K083577HARMONIE SYSTEMGWQ2011-08-29
792281546037074K082629S12X WITH ESAX OPTIONGYC2009-07-01
792281640000293K081551TWIN NEUROTRAC-IIIOMA2008-12-24
792281944018710K053386XLTEK EMU40 EEG HEADBOX, MODEL PK1072GWQ2006-04-21
792281679599393K052112XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059IKN2005-10-28
792281814085303K050425AURA-PSGOLV2005-10-20
792282020694240K043132UNIVERSAL XACTTRACEMNR2004-12-21
792281075840032K042223XLTEK CONNEX IP HEADBOX, MODEL 1054OMB2004-09-16
792282016928225K040360EMU128S, MODEL EX-NW-128SGWQ2004-03-12
792281287769133K033978ADAMGWQ2004-02-18
792281688959849K033010BRM2 BRAIN MONITOROLT2003-10-10
792281893155570K022037XLTEK SLEEP SYSTEMOLV2002-09-10
792281010592937K021807GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEMOLV2002-08-29
792281916823328K012976TWIN PLUSOLV2002-02-12
792281296368249K011794XLTEK LED GOGGLES, MODEL LED-01GWE2001-10-01
792281141148075K010728HARMONE-SCHWARZER EEG SYSTEMOLV2001-05-21
792282000957176K010091EEG WITH VIDEO, MODEL EX-NWGWQ2001-02-01
792281517357641K002332EEG SPIKE AND EVENT DETECTOR MODULEOMB2000-10-06
792281465088545K001103WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED)GWQ2000-06-30
792281127589257
792281951147570

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GWQ142018-06-14
OLV112018-03-09
OMB82020-05-18
MNR42019-09-27
OMA42016-06-03
GWE32018-06-15
IKN22005-10-28
OLT22003-10-10
OMC12024-11-19
GXY12017-11-13
OLZ12011-04-19
OLX12010-12-03
GWF12010-08-11
GYC12009-07-01
GWJ11998-01-30
GWL11996-12-12
EEG11989-04-14