510(k) K251366
- Device
- EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)
- Applicant
- Nihon Kohden Corporation
- 510(k) number
- K251366
- Product code
- OLT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-10-09
- Date received
- 2025-05-01
- Regulation
- 882.1400
- Classification name
- Non-Normalizing Quantitative Electroencephalograph Software
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Sandra Gadeyne
- Address
- 1-31-4 Nishiochiai, Shinijuku-Ku Tokyo JP 161-8560 161-8560
FDA Registration Numbers#
- 3011047165
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