Nicolet Amp 6R11 System
FDA 510(k) K871678 · Nicolet Biomedical Instruments
510(k) numberK871678
Submission
- Device name
- Nicolet Amp 6R11 System
- Applicant
- Nicolet Biomedical Instruments
Madison, WI, US - Received
- April 28, 1987
- Decision date
- July 16, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K230148 | VlabGWL · Traditional | Dormotech Medical, Ltd. | 10/11/2023SE |
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| K220631 | NomadAir PMU810GWL · Traditional | Neurotronics, Inc. | 07/15/2022SE |
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More from Blackrock Microsystems
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| 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 |
| K843598 | Brain Function Mapping Option for PathfGWK · Traditional | 04/11/1985SE |
Questions and answers
When was Nicolet Amp 6R11 System cleared by the FDA?
Nicolet Amp 6R11 System (K871678) received a 510(k) decision of Substantially Equivalent on July 16, 1987, 79 days after the submission was received.
What is the product code of K871678?
The FDA product code is GWL – Amplifier, Physiological Signal, a Class II (moderate risk) device regulated under 21 CFR 882.1835.