FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)
K Number: K251366
·
Decision Oct 9, 2025
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
53
Applicant Total
19
Review Days
161
Basic Information
- Device Name
- EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)
- K Number
- K251366
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nihon Kohden Corporation
- Date Received
- May 1, 2025
- Decision Date
- October 9, 2025
- Product Code
- OLT
- 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 |
|---|---|---|---|
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | FDA class 2 | Neurology |
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