Compact Visual
FDA 510(k) K842613 · Nicolet Biomedical Instruments
510(k) numberK842613
Submission
- Device name
- Compact Visual
- Applicant
- Nicolet Biomedical Instruments
Mchenry, IL, US - Received
- July 5, 1984
- Decision date
- July 20, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IKN – Electromyograph, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1375
- Specialty
- Physical Medicine
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|---|---|---|
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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 |
| K850107 | Concentric Needle Electrodes-Various Sizes W/ConneGXZ · Traditional | 04/11/1985SE |
Questions and answers
When was Compact Visual cleared by the FDA?
Compact Visual (K842613) received a 510(k) decision of Substantially Equivalent on July 20, 1984, 15 days after the submission was received.
What is the product code of K842613?
The FDA product code is IKN – Electromyograph, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 890.1375.