FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Elefix V Paste for EEG & EMG
K Number: K191975
·
Decision Feb 7, 2020
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
68
Applicant Total
19
Review Days
198
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Basic Information
- Device Name
- Elefix V Paste for EEG & EMG
- K Number
- K191975
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1275
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nihon Kohden Corporation
- Date Received
- July 24, 2019
- Decision Date
- February 7, 2020
- Product Code
- GYB
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GYB | Media, Electroconductive | FDA class 2 | Neurology |
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