Nicolet Instrument Corp.
Medical device manufacturer in Madison, WI.
13510(k) clearances
0PMA approvals
0recalls
Device types
- IKN Electromyograph, Diagnostic 2
- GWF Stimulator, Electrical, Evoked Response 2
- GWQ Full-Montage Standard Electroencephalograph 2
- GYC Electrode, Cortical 1
- GWK Conditioner, Signal, Physiological 1
- GWN Nystagmograph 1
- ETW Calibrator, Hearing Aid / Earphone And… 1
- GWS Analyzer, Spectrum, Electroencephalogram… 1
- ESD Hearing Aid, Air-Conduction, Prescription 1
- GWJ Stimulator, Auditory, Evoked Response 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K921138 | Nicolet Ultrasom Acquisition StationGWQ · Traditional | 05/14/1993SE |
| K923315 | Nicolet Ark SystemGWF · Traditional | 11/23/1992SE |
| K921927 | Nicolet VoyageurGWQ · Traditional | 11/05/1992SE |
| K915652 | Nicolet Poratble Spirit SystemGWF · Traditional | 02/07/1992SE |
| K905632 | Nicolet Mapleleaf SystemGWJ · Traditional | 06/07/1991SE |
| K897154 | Nicolet Dbte Hearing Aid: Digital & ProgrammableESD · Traditional | 04/30/1990SE |
| K894629 | Nicolet Beam II SystemGWS · Traditional | 03/09/1990SE |
| K896477 | Nicolet Real Ear AnalyzerETW · Traditional | 02/08/1990SE |
| K883781 | Nicolet Neuroport/Ace SystemIKN · Traditional | 06/05/1989SE |
| K890495 | Nicolet Viking II SystemIKN · Traditional | 03/16/1989SE |
| K884294 | Nicolet Nystar Plus SystemGWN · Traditional | 11/23/1988SE |
| K882599 | Nicolet Brainlab SystemGWK · Traditional | 10/19/1988SE |
| K882053 | Nicolet Epidural Spinal ElectrodeGYC · Traditional | 10/18/1988SE |