Neuropack MEB-9400A
GUDID 00841983103575
MEB-9400 Neuropack S1 desktop system; performs Evoked potentials, Nerve Conduction and Electromyography studies
NIHON KOHDEN AMERICA, INC.
Evoked-potential graphic recording system| Primary Device ID | 00841983103575 |
| NIH Device Record Key | 2346a9cf-673a-45f4-acf1-8981c9b777b2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Neuropack |
| Version Model Number | MEB-9400A |
| Catalog Number | MEB-9400A |
| Company DUNS | 021063219 |
| Company Name | NIHON KOHDEN AMERICA, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | |
| 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 | 00841983103575 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K010590
FDA Product Code
| IKN | Electromyograph, diagnostic |
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 [Neuropack]
| 00841983103582 | MEB-9400 Neuropack S1 Laptop system; performs Evoked potentials, Nerve Conduction and Electromyo |
| 00841983103575 | MEB-9400 Neuropack S1 desktop system; performs Evoked potentials, Nerve Conduction and Electromy |
| 00841983103568 | MEB-2300 Neuropack X1 desktop system; performs Evoked potentials, Nerve Conduction and Electromy |
Trademark Results [Neuropack]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEUROPACK 73467806 1483229 Live/Registered |
NIHON KOHDEN CORPORATION 1984-02-28 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.