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Nicolet Biomedical Instruments

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Devices
26

What Nicolet Biomedical Instruments makes

Nicolet Biomedical Instruments manufactures diagnostic and monitoring devices for neurological, auditory, and cardiovascular assessments, including digital electromyography (EMG) systems, electroencephalography (EEG) accessories, and ventricular function analyzers. Their product line also covers visual and auditory testing systems, disposable probes for evoked potential assessments, and electrodiagnostic platforms for sleep/wake analysis. Hearing aid components and arterial tonometry devices are part of their offerings, alongside specialized tools for brain function mapping and visual testing.

The company’s devices are classified under FDA’s Class I and Class II categories, with most requiring 510(k) clearance. Their products are listed in the FDA’s 510(k) registry, reflecting regulatory compliance for medical devices in the United States. The manufacturer operates from the US, adhering to domestic regulatory requirements for these diagnostic tools.

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

Catalogue26

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  • Emg Surface, Digital Ring, Bar, Grounding, Eeg Ref K850108

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Nicolet Viking Ref K842956

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Nic-200 Ventricular Function Analyzer Ref K792466

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Arteoial Tonometer Ml-105 Ref K771449

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Compact Visual Ref K842613

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Brain Function Mapping Option For Pathf Ref K843598

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Compact Auditory Ref K842612

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Nicolet Disposable Prass Probe Ref K873964

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Pathfinder Electrodiagnostic System Ref K801604

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Vts-1000 Visual Testing System Ref K812331

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Nicolet Expert Sleep/Wake Analysis System Ref K873535

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Nicolet Digital Two Piece Hearing Aid Ref K873736

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Nic Optronics Cs-2000 Ref K822215

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Nicolet Emg Satellite Ref K830702

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Multi-Signal Auditory Stimulator SM700 Ref K830579

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Nystagmograph Eog/Eng Analyses Ref K851190

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • CA2000 Ref K842611

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Compact Four Ref K831896

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Tm-5 Intracranial Pressure Monitor Ref K802149

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Phoenix System Seven. Ref K862592

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Modified Nicolet Viking System Ref K880573

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Electroencephalograph Eeg Ref K850259

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Erg-Jet Electrode Ref K813399

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Stimulator, Nic-106 Visual Ref K790570

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Nicolet Amp 6R11 System Ref K871678

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Concentric Needle Electrodes-Various Sizes W/Conne Ref K850107

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

Rows 1-26 of 26

Frequently asked questions

How many devices does Nicolet Biomedical Instruments have in the registry?

The registry currently lists 26 devices for Nicolet Biomedical Instruments. Devices recorded under merged duplicate company entries are counted once.

Which registries list Nicolet Biomedical Instruments's devices?

Among its 26 most recently registered devices, Nicolet Biomedical Instruments has devices listed in FDA 510(k) (26 devices).

What risk classes do Nicolet Biomedical Instruments's devices fall under?

Among its 26 most recently registered devices, the classes recorded for Nicolet Biomedical Instruments's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Nicolet Biomedical Instruments in the registry?

The most recently registered devices listed for Nicolet Biomedical Instruments include EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG, NICOLET VIKING, NIC-200 VENTRICULAR FUNCTION ANALYZER and ARTEOIAL TONOMETER ML-105.

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