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Natus Neurology Incorporated

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30106119503010611950Natus Neurology Incorporated1Y2026-01-013150 Pleasant View Road Middleton WI US 53562

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1652521827570237K993622NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERYGZL2000-01-24
1652522058424939K991054BRAVO MULTI-MODALITY SYSTEMGWQ1999-11-03
1652521792744973K984052SYNERGY IOM SYSTEMIKN1999-05-17
1652521009839220K982635CAREDOP IIJAF1998-08-07
1652521224276050K973556IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000IYN1998-04-24
1652521296659478K973442TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODESIKT1997-11-20
1652521506770883K973336IMEX STETHODOPJAF1998-02-05
1652522017065780K970156IMEX FUTURALDOP PROIYO1997-04-04
1652521090052636K965065TECA. MILLENNIUMGWF1997-06-20
1652521284325589K964280DG NERVUSGWQ1997-01-27
1652521257216410K944196IMWXDOP IRJAF1995-05-12
1652521111059456K942441IMEXDOP CT+JAF1994-08-23
1652521950286881K913749EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170BZQ1992-07-02
1652521875223480K910462POCKET DOP 3HEP1991-06-24
1652521370039925K910247ZODIAC 901 MIDDLE-EAR ANALYZERETY1991-06-19
1652521983676508K896613FLAT VASCULAR PROBEDPW1990-02-16
1652521665906091K890495NICOLET VIKING II SYSTEMIKN1989-03-16
1652521228256722K850259ELECTROENCEPHALOGRAPH EEGGWQ1985-04-11
1652521091565059K850108EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEGGXY1985-04-11
1652521070658888K790570STIMULATOR, NIC-106 VISUALGWE1979-05-23
1652521186158155K243982Nicolet EDXGWF2025-01-22
1652521826724613K243495Natus Ultrapro S100 (982A0594)GWF2024-12-12
1652521508457958K192572CNS EnvisionOLT2019-12-17
1652521907881057K173366NicoletOneOLZ2018-07-20
1652521294533495K172743Natus VikingQuestIKN2017-12-19
1652521021257109K163617REMbrandtOLZ2017-04-11
1652521233559279K162140RemLogicOLZ2016-12-01
1652521693112397K161707Madsen ZodiacETY2016-09-01
1652521665287755K153353SANDMAN ELITEOLZ2016-06-23
1652521528111313K151504ICS ImpulseGWN2015-11-16
1652521089160083K132957MADSEN ACCUSCREEN TYPE 1077GWJ2014-02-27
1652521334070799K130346SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSIONGWF2013-05-02
1652521300724879K130136DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,GXZ2013-07-19
1652521460152040K122550ICS IMPULSEGWN2013-02-01
1652521701291972K122516EMBLETTA MPRMNR2013-02-21
1652521420828792K122067TYPE 1077 ACCUSCREENGWJ2012-09-27
1652521133926893K122028AURICAL HITETW2012-10-23
1652521964242879K120979CAREFUSION NICOLET EDXGWF2012-04-25
1652521328566265K112052CAREFUSION NICOLET EDXGWF2012-03-15
1652521319318100K112034TECA ELITE DISPOSABLE CONCENTRIC NEEDLESIKT2011-08-12
1652521580924089K111742MDRIVEMNR2011-08-31
1652521007814735K111131TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLESIKT2011-06-17
1652521251661732K110286GN OTOMETRICS TYPE 1053 FREEFITETW2011-04-28
1652521911000161K103140NICOLET WIRELESS EEGGWL2011-04-08
1652521023853948K083399ICS CHARTR EP 200GWJ2009-02-20
1652521331377213K081234GN OTOMETRICS INSERT EARPHONESEWO2008-07-14
1652521867834542K080217COMPONENT NEUROMONITORING SYSTEMOMA2008-11-05
1652521909736227K072964NICOLET CORTICAL STIMULATORGYC2008-12-30
1652521648309051K070907INTERSON USB ULTRASOUND PROBE SYSTEMIYO2007-04-17
1652521278642662K061908NICOLETONE SYSTEM V32 AMPLIFIERGWQ2006-11-06
1652521486591463K061791FOCUS VNG/ENG TYPE 1068GWN2006-07-11
1652521664740214K060421SONARA; SONARA/TEKIYN2006-11-03
1652521135621611K053648PIONEER TC8080, COMPANION IIIIYN2006-01-24
1652521814085303K050425AURA-PSGOLV2005-10-20
1652522020694240K043132UNIVERSAL XACTTRACEMNR2004-12-21
1652521885654819K041904COMPASS F10 SYSTEMMNR2004-09-07
1652521012839689K041198NIC36 AMPLIFIERGWL2004-06-01
1652522022410490K033645OTOFLEX 100 TYE 1012ETY2004-03-31
1652521889396993K024322EMBLA N7000MNR2003-10-27
1652521056893419K021185NERVUS MONITOROLV2002-07-12
1652521521584616K013281VERSALAB APMHGM2002-04-18
1652521626415462K011818STERILE EMG ELECTRODESIKT2001-09-06
1652521225763279K010521NICOLET VERSALABJAF2001-03-09
1652521624782241K010460LIFELINES TRACKITOLV2001-05-14
1652521117151128K003154MIZAR, BASIS BE, SANDMAN DIGITALGWL2001-01-05
1652522050617929K002766NICOLET VASOGUARDJOP2000-11-30
1652521592499800K002200CAPELLAEWO2000-08-25
1652521975506691K001467DA VINCHI EMG/EP ISA1004EPGWE2000-08-01
1652521577442822K000963DA VINCHI EEG AND EMG/EP SYSTEMSGWF2000-10-20
1652521738273059K000338VITAPORT 3OLV2000-04-26
1652521156966802
1652521478777801
1652521586415305
1652521687671386
1652521018816242
1652521095558818
1652521204011015
1652521252474318
1652521336246844
1652521338367226
1652521403261951
1652521441410452
1652521489322299
1652521619446774
1652521651549779
1652521754977808
1652521860638933
1652521927002126
1652521931539437
1652521951147570

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GWF72025-01-22
MNR52013-02-21
JAF52001-03-09
OLZ42018-07-20
IKT42011-08-12
GWQ42006-11-06
OLV42005-10-20
IKN32017-12-19
ETY32016-09-01
GWN32015-11-16
GWJ32014-02-27
GWL32011-04-08
IYN32006-11-03
ETW22012-10-23
EWO22008-07-14
IYO22007-04-17
GWE22000-08-01
OLT12019-12-17
GXZ12013-07-19
GYC12008-12-30
OMA12008-11-05
HGM12002-04-18
JOP12000-11-30
GZL12000-01-24
BZQ11992-07-02
HEP11991-06-24
DPW11990-02-16
GXY11985-04-11

PMN#

GUDID#

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