Satellite
FDA 510(k) K971331 · Nicolet Biomedical, Inc.
510(k) numberK971331
Submission
- Device name
- Satellite
- Applicant
- Nicolet Biomedical, Inc.
Madison, WI, US - Received
- April 10, 1997
- Decision date
- June 25, 1997
- 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 |
|---|---|---|
| K020754 | Nicolet Pioneer TC8080IYN · Abbreviated | 04/21/2003SE |
| K021986 | BrainetGXY · Traditional | 08/23/2002SE |
| K021144 | Subdural Strip ElectrodeGYC · Abbreviated | 06/24/2002SE |
| K020218 | Snap EEG MonitorOLW · Abbreviated | 04/22/2002SE |
| K013281 | Versalab ApmHGM · Abbreviated | 04/18/2002SE |
| K020955 | Nicolet Electrocautery DetectorETN · Abbreviated | 04/17/2002SE |
| K013419 | Nicolet Electromagnetic Navigation SystemLLZ · Traditional | 12/20/2001SE |
| K011823 | Biorehab SystemHCC · Abbreviated | 09/06/2001SE |
| K011818 | Sterile Emg ElectrodesIKT · Abbreviated | 09/06/2001SE |
| K011135 | Gsi AuderaEWO · Traditional | 07/26/2001SE |
Questions and answers
When was Satellite cleared by the FDA?
Satellite (K971331) received a 510(k) decision of Substantially Equivalent on June 25, 1997, 76 days after the submission was received.
What is the product code of K971331?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.