Neurofax EEG-1260A
GUDID 00841983104329
NEUROFAX ACQUISITION, SML FRM
NIHON KOHDEN AMERICA, INC.
Electroencephalograph| Primary Device ID | 00841983104329 |
| NIH Device Record Key | 96c79642-3fd1-4a9d-aa09-20305afc3509 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Neurofax |
| Version Model Number | EEG-1260A |
| Catalog Number | EEG-1260A |
| Company DUNS | 021063219 |
| Company Name | NIHON KOHDEN AMERICA, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841983104329 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K080546
FDA Product Code
| OLT | Non-normalizing quantitative electroencephalograph software |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-16 |
| Device Publish Date | 2021-08-06 |
On-Brand Devices [Neurofax]
| 00841983103988 | MEDICAL ISOLATION TRANSFORMER |
| 00841983103971 | NEUROFAX ACQUISITION, Dell Precision Tower desktop |
| 00841983103926 | EEG REVIEW SUITE, 5 USER LICENSE |
| 00841983103919 | EEG REVIEW SUITE, 10 USER LICENSE |
| 00841983103858 | LIVE VIEW PANEL SYSTEM |
| 00841983103841 | EEG REVIEW SYSTEM |
| 00841983103834 | 256 CHANNEL AMPLIFIER for JE-120A |
| 00841983103827 | 192 CHANNEL AMPLIFIER for JE-120A |
| 00841983103810 | 128 CHANNEL AMPLIFIER for JE-120A |
| 00841983103803 | NEUROFAX EEG DIGITAL, PORTABLE |
| 00841983103797 | NEUROFAX ACQUISITION, PANEL PC |
| 00841983103773 | NEUROFAX ACQUISITION, SML FRM |
| 00841983103650 | EEG REVIEW SUITE, MULTIUSE |
| 00841983103209 | NEUROFAX EEG DIGITAL, TOWER |
| 00841983102417 | Neurofax Electroencephalograph |
| 00841983104329 | NEUROFAX ACQUISITION, SML FRM |
Trademark Results [Neurofax]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEUROFAX 73597401 1433703 Live/Registered |
NIHON KOHDEN CORPORATION 1986-05-07 |
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