CNS Satellite 100, 200, 1000, 2000 Electroence.
FDA 510(k) K901549 · Cns, Inc.
510(k) numberK901549
Submission
- Device name
- CNS Satellite 100, 200, 1000, 2000 Electroence.
- Applicant
- Cns, Inc.
Eden Prairie, MN, US - Received
- April 3, 1990
- Decision date
- October 24, 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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| 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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| K910452 | Respi-Pak Rt-PakBZG · Traditional | 04/16/1991SE |
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Questions and answers
When was CNS Satellite 100, 200, 1000, 2000 Electroence. cleared by the FDA?
CNS Satellite 100, 200, 1000, 2000 Electroence. (K901549) received a 510(k) decision of Substantially Equivalent on October 24, 1990, 204 days after the submission was received.
What is the product code of K901549?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.