Brain Function Mapping Option for Pathf
FDA 510(k) K843598 · Nicolet Biomedical Instruments
510(k) numberK843598
Submission
- Device name
- Brain Function Mapping Option for Pathf
- Applicant
- Nicolet Biomedical Instruments
Madison, WI, US - Received
- September 12, 1984
- Decision date
- April 11, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| 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 Brain Function Mapping Option for Pathf cleared by the FDA?
Brain Function Mapping Option for Pathf (K843598) received a 510(k) decision of Substantially Equivalent on April 11, 1985, 211 days after the submission was received.
What is the product code of K843598?
The FDA product code is GWK – Conditioner, Signal, Physiological, a Class II (moderate risk) device regulated under 21 CFR 882.1845.