Nicolet Voyageur
FDA 510(k) K921927 · Nicolet Instrument Corp.
510(k) numberK921927
Submission
- Device name
- Nicolet Voyageur
- Applicant
- Nicolet Instrument Corp.
Madison, WI, US - Received
- April 24, 1992
- Decision date
- November 5, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GWQ – Full-Montage Standard Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations
Other 510(k)s with product code GWQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261604 | Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)GWQ · Special | Neuroelectrics Barcelona S.L.U. | 06/13/2026SE |
| K260455 | New Wave SystemGWQ · Special | Zeto, Inc. | 03/13/2026SE |
| K233403 | Flexset SystemGWQ · Traditional | Zeto, Inc. | 04/30/2024SE |
| K231366 | Neuronaute PlusGWQ · Traditional | Bioserenity Sas | 11/09/2023SE |
| K221959 | Q21GWQ · Traditional | Neurofield, Inc. | 08/31/2023SE |
| K231457 | SPARK ScanGWQ · Traditional | Spark Neuro, Inc. | 08/18/2023SE |
| K221963 | Cumulus Functional Neurophysiology PlatformGWQ · Traditional | Cumulus Neuroscience Limited | 04/27/2023SE |
| K230073 | OktiGWQ · Traditional | Compumedics Limited | 02/09/2023SE |
| K223644 | Neuronaute with IceCap 2 & IceCap 2 SmallGWQ · Special | Bioserenity | 01/12/2023SE |
| K220056 | iSyncWaveGWQ · Traditional | iMediSync, Inc. | 08/10/2022SE |
More from iMediSync, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K921138 | Nicolet Ultrasom Acquisition StationGWQ · Traditional | 05/14/1993SE |
| K923315 | Nicolet Ark SystemGWF · Traditional | 11/23/1992SE |
| 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 |
Questions and answers
When was Nicolet Voyageur cleared by the FDA?
Nicolet Voyageur (K921927) received a 510(k) decision of Substantially Equivalent on November 5, 1992, 195 days after the submission was received.
What is the product code of K921927?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.