Elefix V Paste for EEG & EMG
FDA 510(k) K191975 · Nihon Kohden Corporation
510(k) numberK191975
Submission
- Device name
- Elefix V Paste for EEG & EMG
- Applicant
- Nihon Kohden Corporation
Tokyo, JP - Received
- July 24, 2019
- Decision date
- February 7, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Elefix V Paste for EEG & EMG cleared by the FDA?
Elefix V Paste for EEG & EMG (K191975) received a 510(k) decision of Substantially Equivalent on February 7, 2020, 198 days after the submission was received.
What is the product code of K191975?
The FDA product code is GYB – Media, Electroconductive, a Class II (moderate risk) device regulated under 21 CFR 882.1275.