Pathfinder Electrodiagnostic System
FDA 510(k) K801604 · Nicolet Biomedical Instruments
510(k) numberK801604
Submission
- Device name
- Pathfinder Electrodiagnostic System
- Applicant
- Nicolet Biomedical Instruments
Mchenry, IL, US - Received
- July 14, 1980
- Decision date
- August 4, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| 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 Pathfinder Electrodiagnostic System cleared by the FDA?
Pathfinder Electrodiagnostic System (K801604) received a 510(k) decision of Substantially Equivalent on August 4, 1980, 21 days after the submission was received.
What is the product code of K801604?
The FDA product code is GWK – Conditioner, Signal, Physiological, a Class II (moderate risk) device regulated under 21 CFR 882.1845.