Compact Four
FDA 510(k) K831896 · Nicolet Biomedical Instruments
510(k) numberK831896
Submission
- Device name
- Compact Four
- Applicant
- Nicolet Biomedical Instruments
Walker, MI, US - Received
- June 14, 1983
- Decision date
- July 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K253301 | BraiN20® (BraiN20)GWF · Traditional | Time IS Brain, S.L. | 06/27/2026SE |
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| K243982 | Nicolet EDXGWF · Special | Natus Neurology Incorporated | 01/22/2025SE |
| K243495 | Natus Ultrapro S100 (982A0594)GWF · Special | Natus Neurology Incorporated | 12/12/2024SE |
| K242345 | Delphi StimulatorGWF · Traditional | Quantalx Neuroscience | 11/05/2024SE |
| K234092 | SafeOp 3: Neural Informatix SysteemGWF · Traditional | Alphatec Spine, Inc. | 04/19/2024SE |
| K234080 | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)GWF · Traditional | Soterix Medical, Inc. | 03/25/2024SE |
| K233292 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressGWF · Special | Inomed Medizintechnik GmbH | 10/27/2023SE |
| K230415 | Cadwell GuardianGWF · Traditional | Cadwell Industries, Inc. | 08/17/2023SE |
| K213849 | SafeOp 2: Neural Informatix SystemGWF · Traditional | Alphatec Spine, Inc. | 03/09/2022SE |
More from Alphatec Spine, Inc.
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|---|---|---|
| K880573 | Modified Nicolet Viking SystemIKN · Traditional | 03/22/1988SE |
| K873736 | Nicolet Digital Two Piece Hearing AidESD · Traditional | 12/08/1987SE |
| K873964 | Nicolet Disposable Prass ProbeETN · Traditional | 11/20/1987SE |
| K873535 | Nicolet Expert Sleep/Wake Analysis SystemGWQ · Traditional | 10/26/1987SE |
| K871678 | Nicolet Amp 6R11 SystemGWL · Traditional | 07/16/1987SE |
| K862592 | Phoenix System Seven.EWO · Traditional | 09/16/1986SE |
| K851190 | Nystagmograph Eog/Eng AnalysesGWN · Traditional | 11/27/1985SE |
| K850259 | Electroencephalograph EEGGWQ · Traditional | 04/11/1985SE |
| K850108 | Emg Surface, Digital Ring, Bar, Grounding, EEGGXY · Traditional | 04/11/1985SE |
| K850107 | Concentric Needle Electrodes-Various Sizes W/ConneGXZ · Traditional | 04/11/1985SE |
Questions and answers
When was Compact Four cleared by the FDA?
Compact Four (K831896) received a 510(k) decision of Substantially Equivalent on July 28, 1983, 44 days after the submission was received.
What is the product code of K831896?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.