Stimulator, NIC-106 Visual
FDA 510(k) K790570 · Nicolet Biomedical Instruments
510(k) numberK790570
Submission
- Device name
- Stimulator, NIC-106 Visual
- Applicant
- Nicolet Biomedical Instruments
Mchenry, IL, US - Received
- March 23, 1979
- Decision date
- May 23, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| 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 |
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Questions and answers
When was Stimulator, NIC-106 Visual cleared by the FDA?
Stimulator, NIC-106 Visual (K790570) received a 510(k) decision of Substantially Equivalent on May 23, 1979, 61 days after the submission was received.
What is the product code of K790570?
The FDA product code is GWE – Stimulator, Photic, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1890.