P460, DG32 Electroencephalograph
FDA 510(k) K896666 · Teca, Inc.
510(k) numberK896666
Submission
- Device name
- P460, DG32 Electroencephalograph
- Applicant
- Teca, Inc.
Pleasantiville, NY, US - Received
- November 27, 1989
- Decision date
- February 16, 1990
- 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 |
More from iMediSync, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K962283 | EEG ElectrodesGXY · Traditional | 12/16/1996SE |
| K903731 | Sapphire Series 1P, 1L, 2L, and 2MEGWF · Traditional | 02/04/1991SE |
| K903004 | EE1114, 1118, 1121 Electro-EncephalographGWQ · Traditional | 11/15/1990SE |
| K894889 | Teca Neuromapper 386OLT · Traditional | 12/22/1989SE |
| K894088 | Teca Neuromapper 1620, Brain MapperOLT · Traditional | 11/15/1989SE |
| K890881 | Teca 1A96, 1A97 and 1A98 ElectroencephalographsGWQ · Traditional | 03/23/1989SE |
| K884870 | Teca/Medelec 'Concept' P420GWF · Traditional | 02/23/1989SE |
| K880593 | Teca/Medelec MistralGWE · Traditional | 04/06/1988SE |
| K872931 | Teca/Medelec TTT Thermal Threshold TesterLLN · Traditional | 11/16/1987SE |
| K862906 | Teca/Medelec AS-10 SensorGWJ · Traditional | 02/04/1987SE |
Questions and answers
When was P460, DG32 Electroencephalograph cleared by the FDA?
P460, DG32 Electroencephalograph (K896666) received a 510(k) decision of Substantially Equivalent on February 16, 1990, 81 days after the submission was received.
What is the product code of K896666?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.