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Gn Otometrics A/S

Also registered as Gn Otometrics

Country not established

Devices
14

What Gn Otometrics A/S makes

Gn Otometrics A/S manufactures audiometric and vestibular diagnostic devices, including equipment for pure-tone audiometry (e.g., SPEECHLINK 100), electrocochleography (ICS CHARTR EP 200 with VEMP), and video/nystagmography (FOCUS VNG/ENG). Their portfolio also includes customizable hearing aid fitting systems (GN Otometrics Type 1053 FreeFit) and otoscopic tools (OTOFLEX 100).

These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company’s products are listed in the FDA’s 510(k) database. Gn Otometrics A/S is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue14

Newest first, rows 1-14 of 14

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  • Ics Chartr Ep 200 With Vemp Ref K143670

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ics Chartr Ep 200 Ref K092373

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Speechlink 100 Type 1053 Ref K061104

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ics Impulse Ref K122550

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Type 1077 Accuscreen Ref K122067

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Aurical Hit Ref K122028

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • ICS Impulse Ref K151504

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Gn Otometrics Type 1053 Freefit Ref K110286

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Madsen Accuscreen Type 1077 Ref K132957

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ics Chartr Ep 200 Ref K083399

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Gn Otometrics Insert Earphones Ref K081234

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Madsen Zodiac Ref K161707

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Focus Vng/Eng Type 1068 Ref K061791

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Otoflex 100 Tye 1012 Ref K033645

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-14 of 14

Frequently asked questions

How many devices does Gn Otometrics A/S have in the registry?

The registry currently lists 14 devices for Gn Otometrics A/S. Devices recorded under merged duplicate company entries are counted once.

Which registries list Gn Otometrics A/S's devices?

Among its 14 most recently registered devices, Gn Otometrics A/S has devices listed in FDA 510(k) (14 devices).

What risk classes do Gn Otometrics A/S's devices fall under?

Among its 14 most recently registered devices, the classes recorded for Gn Otometrics A/S's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Gn Otometrics A/S in the registry?

The most recently registered devices listed for Gn Otometrics A/S include ICS CHARTR EP 200 WITH VEMP, ICS CHARTR EP 200, SPEECHLINK 100 TYPE 1053 and ICS IMPULSE.

Generated automatically from registry data and not verified by a human reviewer.