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Nicolet Instrument Corp.

United StatesFDA applicant, unverified

Devices
13

What Nicolet Instrument Corp. makes

Nicolet Instrument Corp. manufactures medical devices for neurological monitoring and hearing assessment, including epidural spinal electrodes for intraoperative and postoperative monitoring, portable systems for continuous patient observation, and real-ear analyzers for audiological testing. Their portfolio also covers programmable hearing aids, brain mapping systems, and neurophysiological monitoring platforms used in operating rooms and intensive care settings.

The company’s devices are classified under FDA’s Class I and Class II categories, with many authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) registry, reflecting compliance with US regulatory requirements. The manufacturer operates from the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue13

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  • Nicolet Epidural Spinal Electrode Ref K882053

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

  • Nicolet Poratble Spirit System Ref K915652

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

  • Nicolet Beam Ii System Ref K894629

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

  • Nicolet Dbte Hearing Aid: Digital & Programmable Ref K897154

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

  • Nicolet Mapleleaf System Ref K905632

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

  • Nicolet Nystar Plus System Ref K884294

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

  • Nicolet Viking Ii System Ref K890495

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

  • Nicolet Real Ear Analyzer Ref K896477

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

  • Nicolet Voyageur Ref K921927

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

  • Nicolet Brainlab System Ref K882599

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

  • Nicolet Ark System Ref K923315

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

  • Nicolet Neuroport/Ace System Ref K883781

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

  • Nicolet Ultrasom Acquisition Station Ref K921138

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

Rows 1-13 of 13

Frequently asked questions

How many devices does Nicolet Instrument Corp. have in the registry?

The registry currently lists 13 devices for Nicolet Instrument Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Nicolet Instrument Corp.'s devices?

Among its 13 most recently registered devices, Nicolet Instrument Corp. has devices listed in FDA 510(k) (13 devices).

What risk classes do Nicolet Instrument Corp.'s devices fall under?

Among its 13 most recently registered devices, the classes recorded for Nicolet Instrument Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Nicolet Instrument Corp. in the registry?

The most recently registered devices listed for Nicolet Instrument Corp. include NICOLET EPIDURAL SPINAL ELECTRODE, NICOLET PORATBLE SPIRIT SYSTEM, NICOLET BEAM II SYSTEM and NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE.

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