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Data / Medical devices / Denmark / Interacoustics A/S

Interacoustics A/S: FDA-registered device maker in Middelfart Syddanmark, Denmark, 32 510(k) clearances

Interacoustics A/S is registered with the FDA (registration 9710051) in Middelfart Syddanmark, Denmark. It lists 16 device types. The FDA files 32 510(k) clearances under its listings, the newest dated August 12, 2020. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Interacoustics A/S
FDA registration number
9710051
FEI number
3000254565
Address
Audiometer Alle 1, Middelfart Syddanmark, Denmark, 5500
Owner or operator
DEMANT A/S (8010048)
Roles
Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
First device listed
September 21, 1994
Registered through
2026
Brand names listed
2D-VOG Goggles, 2D-VOG System, 2D-VOGfw, AA222, ABRIS, AC 440 Module, AC33, AC40 and more

Devices it lists

DeviceProduct codeClassRoleSource
Apparatus, Vestibular AnalysisLXVUComplaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
AudiometerEWO2Complaint file establishment, Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Cable, ElectrodeIKD2Manufactureraccessdata.fda.gov
Calibrator, Hearing Aid / Earphone And Analysis SystemsETW2Manufactureraccessdata.fda.gov
Cushion, Earphone (For Audiometric Testing)ETT1Complaint file establishment, Specification developeraccessdata.fda.gov
Electrode, CutaneousGXY2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Medical Device Data SystemOUG1Manufactureraccessdata.fda.gov
NystagmographGWN2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
OtoscopeERA1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Rhinoanemometer (Measurement Of Nasal Decongestion)BXQ2Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Set, Audiometer CalibrationEWA1Manufactureraccessdata.fda.gov
Stimulator, Auditory, Evoked ResponseGWJ2Complaint file establishment, Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Stimulator, Caloric-AirKHH1Specification developeraccessdata.fda.gov
Stimulator, Caloric-WaterETP1Specification developeraccessdata.fda.gov
Tester, Auditory ImpedanceETY2Complaint file establishment, Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Tester, Auditory Impedance, ExemptPTO2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 12, 2020K200534VisualEyesGWNSubstantially EquivalentInteracoustics A/Saccessdata.fda.gov
May 27, 2020K192652TRVLXVSubstantially EquivalentInteracoustics A/Saccessdata.fda.gov
July 15, 2019K191372LyraEWOSubstantially EquivalentInteracoustics A/Saccessdata.fda.gov
February 14, 2018K173567SeraEWOSubstantially EquivalentInteracoustics A/Saccessdata.fda.gov
April 26, 2017K163149VisualEyesGWNSubstantially EquivalentInteracoustics A/Saccessdata.fda.gov
December 29, 2015K152112VisualEyesGWNSubstantially EquivalentInteracoustics A/Saccessdata.fda.gov
July 15, 2015K151616AT235ETYSubstantially EquivalentInteracoustics A/Saccessdata.fda.gov
March 26, 2015K150491ER36 Series OAE Test SystemEWOSubstantially EquivalentEtymotic Research, Inc.accessdata.fda.gov
September 6, 2013K131681EYESEECAM VHITGWNSubstantially EquivalentInteracoustics A/Saccessdata.fda.gov
October 14, 2011K111737DISPOSABLE ELECTRODEGXYSubstantially EquivalentSanibel Supplyaccessdata.fda.gov
December 23, 2010K102364NYDIAG 200LXVSubstantially EquivalentInteracoustics A/Saccessdata.fda.gov
April 9, 2009K083861TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITEETYSubstantially EquivalentInteracoustics ASaccessdata.fda.gov
January 29, 2009K082035MAICO MB 11 WITH BERAPHONE PROBEGWJSubstantially EquivalentMaico Diagnosticsaccessdata.fda.gov
February 5, 2008K072254VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEMGWNSubstantially EquivalentInteracoustics A/Saccessdata.fda.gov
June 29, 2007K070696INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)GWJSubstantially EquivalentInteracoustics A/Saccessdata.fda.gov
May 30, 2006K060539DPOAE20 , ECLIPSEEWOSubstantially EquivalentInteracoustics A/S, Assensaccessdata.fda.gov
December 23, 2005K052562ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.EWOSubstantially EquivalentInteracoustics ASaccessdata.fda.gov
April 29, 2005K050496REM440ETWSubstantially EquivalentInteracoustics A/S, Assensaccessdata.fda.gov
February 4, 2005K043219AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMSEWOSubstantially EquivalentInteracoustics ASaccessdata.fda.gov
March 28, 2003K030016TEOAE25EWOSubstantially EquivalentInteracoustics A/S, Assensaccessdata.fda.gov
October 11, 2002K022728AUDIOTRAVELLER, MODEL AA222ETYSubstantially EquivalentInteracoustics A/S, Assensaccessdata.fda.gov
October 4, 2002K022311RHINOSTREAM RHINOMANOMETER MODULEBXQSubstantially EquivalentRhino Metrics A/Saccessdata.fda.gov
August 24, 2001K011746MB 11GWJSubstantially EquivalentMaico Diagnostic GmbHaccessdata.fda.gov
July 3, 2001K011114ETYMOTIC RESEARCH ER-10D OAE PROBEEWOSubstantially EquivalentEtymotic Researchaccessdata.fda.gov
March 12, 2001K010165ERO SCAN OAE TEST SYSTEMEWOSubstantially EquivalentEtymotic Researchaccessdata.fda.gov
April 17, 2000K000406RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULEBXQSubstantially EquivalentRhino Metrics A/Saccessdata.fda.gov
March 14, 2000K994254INTERACOUSTICS AT235 IMPEDANCE AUDIOMETERETYSubstantially EquivalentInternational Distributors of Electronics For Mediaccessdata.fda.gov
January 25, 1999K983832INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETERETYSubstantially EquivalentIdem (Int'L Dist. of Electronics For Medicine)accessdata.fda.gov
May 23, 1994K941848INTERACOUSTICS. HEARING AID ANALYZERETWSubstantially EquivalentPrecision Acoustics Ind., Inc.accessdata.fda.gov
September 29, 1993K930553CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENTEWOSubstantially EquivalentEtymotic Researchaccessdata.fda.gov
November 24, 1987K873298ELEC-TIPGXYSubstantially EquivalentEtymotic Researchaccessdata.fda.gov
March 23, 1987K863424COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLEGWNSubstantially EquivalentMicromedical Technologies, Inc.accessdata.fda.gov

Compare with other makers

Updated August 12, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.