Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710051

FEI Number

3000254565

Entity Name

INTERACOUSTICS A/S

City/State/Country

Middelfart Syddanmark, DK

Establishment Address

Audiometer Alle 1, Middelfart Syddanmark 5500, DK

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

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

K151616

PMA Number

N/A

All Registered Proprietary Names

AT235, AT235h Lyra VisualEyes EyeSeeCam vHIT VisualEyes 515 2D-VOGfw VisualEyes 525 VisualEyes 505 Orion Comprehensive Basic Orion Autotraverse Basic USBM2.1 BG4 Vorteq Digital Light Bar Datalink Sanibel ETU Universal Electrode Cable, Blue Sanibel ETU Universal Electrode Cable, White Pinch clip cable Cable for TM ECochG electrode ETB Standard electrode cable kit Button electrode cable Jumper cable Alligator clip electrode cable Sanibel ETU Universal Electrode Cable, Yellow Sanibel ETU Universal Electrode Cable, Red Sanibel ETU Universal Electrode Cable, Black GSI TympStar Sera MT10 Gold Tiptrodes Gold Eartip Electrode V0425B VN415M VO425M VN415B VO425 VF405M VNG System VN415 VF405 VF405B 2D-VOG Goggles 2D-VOG System DPOAE20 IA OAE Suite ECLIPSE SYSTEMS EP25 EP15 IA OAE Suite EARturtle w/electrodes Infant EarCup w/ electrodes TM electrode for ECochG, starter kit Hear Aid Calibrator System Aqua Stim Welch Allyn TM286 GSI 39 AA222 Orion Nydiag 200 AA222 easyTymp TRV Audera TEOAE25 OtoAccess VisualEyes 525 VisualEyes 515 REM440 GSI AUDIOscreener + GSI AUDIOscreener RHINOSTREAM RHINOMANOMETER MODULE RHINOSCAN MODEL SRE2000/ SRE2100 Affinity 2 Equinox Affinity Compact Affinity Callisto Sanibel REM Probe Tubes, type A Sanibel REM Probe Tubes, type D Type B probe tube AC 440 Module Probe tubes, type A Sanibel REM Probe Tubes, type C HIT 440 Module EN415 EO425 Meta-4 VIOT Viot Suite OtoRead Air Fx MB 11 with BERAPhone Probe AT235

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2014-03-13
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2019-07-17
GWN	Nystagmograph	Neurology	Class 2	882.1460	2020-11-06
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2013-01-14
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2013-01-11
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
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2007-04-02
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2019-05-23
GWN	Nystagmograph	Neurology	Class 2	882.1460	2008-12-18
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2014-03-13
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2008-12-18
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2008-12-18
ETW	Calibrator, Hearing Aid / Earphone And Analysis Systems	Ear, Nose, Throat	Class 2	874.3310	2007-04-02
ETP	Stimulator, Caloric-Water	Ear, Nose, Throat	Class 1	874.1800	2013-08-22
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	2014-03-13
LXV	Apparatus, Vestibular Analysis	Unknown	Class U	N/A	2011-03-07
PTO	Tester, Auditory Impedance, Exempt	Ear, Nose, Throat	Class 2	874.1090	2017-07-14
LXV	Apparatus, Vestibular Analysis	Unknown	Class U	N/A	2020-05-28
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
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2008-12-18
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2011-04-19
GWN	Nystagmograph	Neurology	Class 2	882.1460	2016-08-01
ETW	Calibrator, Hearing Aid / Earphone And Analysis Systems	Ear, Nose, Throat	Class 2	874.3310	2014-03-13
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2013-01-11
BXQ	Rhinoanemometer (Measurement Of Nasal Decongestion)	Anesthesiology	Class 2	868.1800	2004-01-28
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2011-12-29
ETW	Calibrator, Hearing Aid / Earphone And Analysis Systems	Ear, Nose, Throat	Class 2	874.3310	2011-12-29
GWN	Nystagmograph	Neurology	Class 2	882.1460	2013-08-22
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2011-03-24
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2014-03-13
KHH	Stimulator, Caloric-Air	Ear, Nose, Throat	Class 1	874.1800	2013-08-22
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2014-03-28
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2015-12-14

Official Correspondent

No official correspondent registered.

US Agent Details

Brandon Bell Business: Grason-Stadler Email: bnbl@grason-stadler.com Phone: (952) 9476097

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
K833045	American Electromedics Corp.	CLINICAL TYMPANOMETER	1983-12-08
K780270	Maico Hearing Instruments, Inc.	COMPUTER AUDIOMETER - MA26	1978-02-27
K923074	Life-Tech Intl., Inc.	DANPLEX SCREENING AUDIOMETER	1992-09-23
K010059	Western Systems Research, Inc.	ENGPLUS	2001-02-27
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07

Similar Registrations

Registration Number	Establishment Name	Location
3011310592	DGS Diagnostics Sp. z o.o	Kolbaskowo Zachodniopomorskie, PL
2113281	DIAGNOSTIC GROUP LLC	EDEN PRAIRIE, MN, US
3003138182	AMPLIVOX LTD	Birmingham, GB
9612197	Natus Medical Denmark ApS	TAASTRUP Hovedstaden, DK
3002504821	MAICO Diagnostics GmbH	Berlin, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710051. Last updated year: 2026. Please use registration number 9710051 when referencing this establishment in official correspondence.