Electroencephalograph EEG
FDA 510(k) K850259 · Nicolet Biomedical Instruments
510(k) numberK850259
Submission
- Device name
- Electroencephalograph EEG
- Applicant
- Nicolet Biomedical Instruments
Madison, WI, US - Received
- January 22, 1985
- Decision date
- April 11, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
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| 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.
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|---|---|---|
| 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 |
| 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 |
Questions and answers
When was Electroencephalograph EEG cleared by the FDA?
Electroencephalograph EEG (K850259) received a 510(k) decision of Substantially Equivalent on April 11, 1985, 79 days after the submission was received.
What is the product code of K850259?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.