Ceregrotrac
FDA 510(k) K842784 · Advanced Instruments, Inc.
510(k) numberK842784
Submission
- Device name
- Ceregrotrac
- Applicant
- Advanced Instruments, Inc.
- Received
- July 17, 1984
- Decision date
- January 10, 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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| 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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| K925970 | Model 3D3 OsmometerJJM · Traditional | 07/09/1993SE |
| K911092 | Osmometer Model 2400JJM · Traditional | 05/22/1991SE |
| K873642 | Osmometer Model 110JJM · Traditional | 10/20/1987SE |
| K863516 | Electronic Metal Locator Model MD-1 · Traditional | 09/30/1986SE |
Questions and answers
When was Ceregrotrac cleared by the FDA?
Ceregrotrac (K842784) received a 510(k) decision of Substantially Equivalent on January 10, 1985, 177 days after the submission was received.
What is the product code of K842784?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.