Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2113281

FEI Number

2113281

Entity Name

DIAGNOSTIC GROUP LLC

City/State/Country

EDEN PRAIRIE, MN, US

Establishment Address

10395 W 70th St, EDEN PRAIRIE, MN 55344, US

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DEMANT A/S (Owner Number: 8010048)

Owner / Operator Contact Address

KONGEBAKKEN 9, --, SMORUM, DK-NOTA DK-2765, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Audera Ero-Scan Pro AT235 PILOT TEST Welch Allyn TM286 GSI 39 Race Car MI 22 Otowave 302+ Otowave 102-C Otowave 302 MB 11 GSI Corti Welch Allyn OAE GSI TympStar Otowave 202 GSI Allegro Welch Allyn MicroTymp 4 Sera GSI Novus MI 23 Titan easyTymp Pro easyTymp MI 26 MI 24 MI 20 MB 11 with BERAPhone Probe OtoWave GSI AudioSol GSI 61 AD226 GSI AudioStar Pro Amplivox 240 Wizard Ultra RA660 Avant ARC AC40 AS608 MA28 Amplivox 116 Amplivox 170 AM282 MA39 Amplivox 270 PA5 Amplivox 260 AD229 MA25 AC33 MA41 MA40 AD629 Welch Allyn AM282 MA1 Avant Stealth Audiometer MA42 Amplivox 160 GSI 17 GSI Pello GSI AMTAS MA27 MA52 MA33 Avant A2D+ Audiometer Detective GSI 18 GSI AMTAS Flex SMART TONE Audiometer Luna AD528 CCA-200mini Audiometer RA360 modelONE CCA-100mini Audiometer Fit Test Audiometer NEXT Audiometer Amplivox Otosure easyTone Amplivox PC850 IP30 Insert earphone Amplivox 270+ B71 Bone conductor headset DD45 Headset TDH39 Headset B-81 Bone conductor headset DD65 Headset CIR Insert earphone DD450 High frequency headset Equinox Evo DD65v2 Audiometric headset Touch Keyboard GSI AudioHub

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2014-03-18
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2014-03-18
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2018-02-16
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2018-02-16
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2015-12-14
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2013-01-11
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2013-01-11
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2009-10-12
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2013-01-11
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2021-11-30
NAS	Tympanometer	Ear, Nose, Throat	Class 2	874.1090	2021-11-30
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2007-12-14
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2018-05-14
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2013-01-11
NAS	Tympanometer	Ear, Nose, Throat	Class 2	874.1090	2021-12-01
PTP	Tympanometer, Exempt	Ear, Nose, Throat	Class 2	874.1090	2018-06-26
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2018-03-13
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2018-03-13
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2017-10-20
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2017-10-20
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2020-04-28
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2013-01-11
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2013-01-11
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2011-11-11
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2013-01-11
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2013-01-11
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2014-03-28
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2013-01-11
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	1994-09-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DEMANT A/S

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3032579106	ITSA Medical	Vallauris Alpes-Maritimes, FR
3017441596	Demant Operations, S.a. De C.v.	Tijuana Baja California, MX
2240713	OTICON, INC.	SOMERSET, NJ, US
3002504821	MAICO Diagnostics GmbH	Berlin, DE
3005465494	Oticon A/S	Smorum Hovedstaden, DK

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K780270	Maico Hearing Instruments, Inc.	COMPUTER AUDIOMETER - MA26	1978-02-27
K923074	Life-Tech Intl., Inc.	DANPLEX SCREENING AUDIOMETER	1992-09-23
K833045	American Electromedics Corp.	CLINICAL TYMPANOMETER	1983-12-08

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3013598036	WAHTS Hearing LLC	West Lebanon, NH, US
3043496923	EARGYM LTD	London London, City of, GB
3005019184	Sivantos GmbH	Erlangen Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2113281. Last updated year: 2026. Please use registration number 2113281 when referencing this establishment in official correspondence.