NEUROFAX EEG-9200A
GUDID 00841983103209
NEUROFAX EEG DIGITAL, TOWER
NIHON KOHDEN AMERICA, INC.
Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph| Primary Device ID | 00841983103209 |
| NIH Device Record Key | 4843ddae-7cd1-4558-81cc-e59b60db6cfa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NEUROFAX |
| Version Model Number | EEG-9200A |
| Catalog Number | EEG-9200A |
| 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 | true |
| 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 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
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| 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 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| Phone | +1(800)325-0283 |
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| 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 |
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| Phone | +1(800)325-0283 |
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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841983103209 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K011204
FDA Product Code
| OLV | Standard polysomnograph with electroencephalograph |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |
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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