Nicolet Biomedical Instruments
Medical device manufacturer in Madison, WI.
26510(k) clearances
0PMA approvals
0recalls
Device types
- IKN Electromyograph, Diagnostic 6
- GWK Conditioner, Signal, Physiological 2
- GWQ Full-Montage Standard Electroencephalograph 2
- ESD Hearing Aid, Air-Conduction, Prescription 1
- DXN System, Measurement, Blood-Pressure… 1
- ETN Stimulator, Nerve 1
- GWL Amplifier, Physiological Signal 1
- EWO Audiometer 1
- GWN Nystagmograph 1
- GXY Electrode, Cutaneous 1
- GXZ Electrode, Needle 1
- GWF Stimulator, Electrical, Evoked Response 1
- GWJ Stimulator, Auditory, Evoked Response 1
- HOX Chart, Visual Acuity 1
- HLZ Electrode, Corneal 1
- HLX Photostimulator, Ac-Powered 1
- GWM Device, Monitoring, Intracranial Pressure 1
- DQC Phonocardiograph 1
- GWE Stimulator, Photic, Evoked Response 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K880573 | Modified Nicolet Viking SystemIKN · Traditional | 03/22/1988SE |
| K873736 | Nicolet Digital Two Piece Hearing AidESD · Traditional | 12/08/1987SE |
| K873964 | Nicolet Disposable Prass ProbeETN · Traditional | 11/20/1987SE |
| K873535 | Nicolet Expert Sleep/Wake Analysis SystemGWQ · Traditional | 10/26/1987SE |
| K871678 | Nicolet Amp 6R11 SystemGWL · Traditional | 07/16/1987SE |
| K862592 | Phoenix System Seven.EWO · Traditional | 09/16/1986SE |
| K851190 | Nystagmograph Eog/Eng AnalysesGWN · Traditional | 11/27/1985SE |
| K850259 | Electroencephalograph EEGGWQ · Traditional | 04/11/1985SE |
| K850108 | Emg Surface, Digital Ring, Bar, Grounding, EEGGXY · Traditional | 04/11/1985SE |
| K850107 | Concentric Needle Electrodes-Various Sizes W/ConneGXZ · Traditional | 04/11/1985SE |
| K843598 | Brain Function Mapping Option for PathfGWK · Traditional | 04/11/1985SE |
| K842956 | Nicolet VikingIKN · Traditional | 08/03/1984SE |
| K842613 | Compact VisualIKN · Traditional | 07/20/1984SE |
| K842612 | Compact AuditoryIKN · Traditional | 07/20/1984SE |
| K842611 | CA2000IKN · Traditional | 07/20/1984SE |
| K831896 | Compact FourGWF · Traditional | 07/28/1983SE |
| K830702 | Nicolet Emg SatelliteIKN · Traditional | 07/12/1983SE |
| K830579 | Multi-Signal Auditory Stimulator SM700GWJ · Traditional | 03/08/1983SE |
| K822215 | Nic Optronics CS-2000HOX · Traditional | 08/31/1982SE |
| K813399 | Erg-Jet ElectrodeHLZ · Traditional | 01/22/1982SE |
| K812331 | VTS-1000 Visual Testing SystemHLX · Traditional | 11/16/1981SE |
| K802149 | TM-5 Intracranial Pressure MonitorGWM · Traditional | 11/12/1980SE |
| K801604 | Pathfinder Electrodiagnostic SystemGWK · Traditional | 08/04/1980SE |
| K792466 | NIC-200 Ventricular Function AnalyzerDQC · Traditional | 01/24/1980SE |
| K790570 | Stimulator, NIC-106 VisualGWE · Traditional | 05/23/1979SE |
| K771449 | Arteoial Tonometer ML-105DXN · Traditional | 09/06/1977SE |