Mentor EEG System
FDA 510(k) K904763 · Oxford Medilog, Inc.
510(k) numberK904763
Submission
- Device name
- Mentor EEG System
- Applicant
- Oxford Medilog, Inc.
Clearwater, FL, US - Received
- October 22, 1990
- Decision date
- April 10, 1991
- 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
Other 510(k)s with product code GWQ
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| 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 |
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| K923737 | Model Medilog RapideBZQ · Traditional | 01/05/1994SE |
| K920295 | Medilog Excel ECG Analysis System (Modified)DQK · Traditional | 08/18/1992SE |
| K912890 | Model Sonicaid AxisHGM · Traditional | 01/09/1992SE |
| K912639 | Sonicaid TeamHGM · Traditional | 12/31/1991SE |
| K902690 | Sonicaid Model Meridian 800HGM · Traditional | 02/05/1991SE |
| K895909 | Sonicaid Model Vasoflo 4MAA · Traditional | 07/09/1990SE |
| K896535 | Medilog OptimaDSK · Traditional | 01/18/1990SE |
| K891383 | Medilog 9200 EEG Replay/Analysis SystemOLZ · Traditional | 06/01/1989SE |
| K890330 | Medilog 6000-FD Report GeneratorDSI · Traditional | 04/20/1989SE |
| K890338 | Medilog EditorDSI · Traditional | 04/19/1989SE |
Questions and answers
When was Mentor EEG System cleared by the FDA?
Mentor EEG System (K904763) received a 510(k) decision of Substantially Equivalent on April 10, 1991, 170 days after the submission was received.
What is the product code of K904763?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.