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DIAGNOSTIC GROUP LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21132812113281DIAGNOSTIC GROUP LLC1Y2026-01-0110395 W 70th St EDEN PRAIRIE MN US 55344

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
89331317054311K983051AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTERETY1998-11-18
89331410285103K983049AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTERETY1998-11-18
89331527778122K983048AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTEREWO1998-11-17
89331191807391K983046AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTERETY1998-11-17
89331719162443K974237GSI 70 AUDIOPATH SCREENEREWO1998-02-10
89331180788881K953161MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTIONETY1995-07-24
89331571068749K925585GSI 38 AUTO TYMPETY1993-02-02
89331730758049K905704MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENERETY1991-04-30
89331775317290K873298ELEC-TIPGXY1987-11-24
89331528233473K193033GSI Audera ProGWJ2020-04-24
89331246268334K180287GSI CortiEWO2018-05-11
89331590324444K173567SeraEWO2018-02-14
89331599278372K172403GSI NovusEWO2017-10-20
89331411065356K171265Otowave 302 Portable TympanometerNAS2017-07-28
89331063679309K151616AT235ETY2015-07-15
89331836209954K151509GSI TympStar Pro Middle Ear AnalyzerETY2015-06-25
89331116524987K150491ER36 Series OAE Test SystemEWO2015-03-26
89331691079213K150163Otowave 202 Portable TympanometerNAS2015-04-23
89331785035536K112733ER35 ERO-SCAN PRO HEARING TEST SYSTEMEWO2011-12-16
89331355459559K083861TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITEETY2009-04-09
89331673398325K082035MAICO MB 11 WITH BERAPHONE PROBEGWJ2009-01-29
89331648879180K081841AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETERETY2008-07-16
89331066342154K060885MODEL MI 44 TYMPANOMETEREWO2006-06-05
89331561160688K060883PILOT TEST OR DETECTIVE AUDIOMETERSEWO2006-06-23
89331924940323K024205AUDIOSCREENER OAE+ABREWO2003-03-07
89331997550066K011746MB 11GWJ2001-08-24
89331590295551K011135GSI AUDERAEWO2001-07-26
89331169514171K000097GSI 2000 MIDDLE EAR ANALYZERETY2000-04-12
89331006360926
89331048328367
89331528479922

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EWO112018-05-11
ETY112015-07-15
GWJ32020-04-24
NAS22017-07-28
GXY11987-11-24

PMN#

GUDID#