Geodesic EEG System, Model 200
FDA 510(k) K012079 · Electrical Geodesics, Incorporated
510(k) numberK012079
Submission
- Device name
- Geodesic EEG System, Model 200
- Applicant
- Electrical Geodesics, Incorporated
Phoenix, AZ, US - Received
- July 3, 2001
- Decision date
- September 19, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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| 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 |
|---|---|---|
| K131882 | Geodesiceeg System 400 Series (Ges 400)OLT · Traditional | 02/12/2014SE |
| K112353 | Geodesic EEG Mobile 100 (Gem 100)GWQ · Traditional | 02/17/2012SE |
| K092844 | GeosourceOLX · Traditional | 12/21/2010SE |
| K063797 | Geodesic EEG System 300OLT · Special | 01/25/2007SE |
| K043309 | Geodesic Photogrammetry SystemGWQ · Traditional | 01/26/2005SE |
| K033399 | Geodesic EEG System Series 100GWQ · Traditional | 08/04/2004SE |
Questions and answers
When was Geodesic EEG System, Model 200 cleared by the FDA?
Geodesic EEG System, Model 200 (K012079) received a 510(k) decision of Substantially Equivalent on September 19, 2001, 78 days after the submission was received.
What is the product code of K012079?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.