| Primary Device ID | B195LC100 |
| NIH Device Record Key | 189b7852-f6e7-43a8-bdbb-c0b3145f438f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | cognitrace |
| Version Model Number | LC-100 |
| Company DUNS | 313152485 |
| Company Name | eemagine Medical Imaging Solutions GmbH |
| 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 |
| Phone | +493029048404 |
| support@eemagine.com | |
| Phone | +493029048404 |
| support@eemagine.com | |
| Phone | +493029048404 |
| support@eemagine.com | |
| Phone | +493029048404 |
| support@eemagine.com | |
| Phone | +493029048404 |
| support@eemagine.com | |
| Phone | +493029048404 |
| support@eemagine.com | |
| Phone | +493029048404 |
| support@eemagine.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B195LC100 [Primary] |
| GWQ | Full-montage Standard Electroencephalograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-04 |
| Device Publish Date | 2021-07-27 |
| B195SC100 | eeg recording and review |
| B195LC107 | cognitrace component |
| B195LC106 | cognitrace component |
| B195LC105 | cognitrace component |
| B195LC104 | cognitrace component |
| B195LC100 | cognitrace component |