EEG-1260A Neurofax
by Nihon Kohden Corp. United States(FDA 510(k) applicant) GUDID
Product code OLV
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04931921053201 | Date11 Aug 2026 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — GUDID listing Listed
Specification
- Generic Name
- Electroencephalograph
- Model / Ref / Catalog
- EEG-1260A, EEG-1260A-NE
- Description
- Isolation Unit (and PC unit, Display)
- Primary DI / UDI-DI
- 04931921053201
- FDA Product Code
- OLV, OLT, GWQ
- GMDN Term
- Electroencephalograph
- Device Class
- Class II
- Regulation Number
- 882.1400
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Other devices from Nihon Kohden Corp.
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No
Sources (1)
- FDA UDI 3a36af93-5e33-4904-895c-5b83a5ad75b7