| Primary Device ID | B485VIS100 |
| NIH Device Record Key | 709801aa-d45e-43ff-ba15-8f3da4b6ca4f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CNS Envision |
| Version Model Number | VIS-100 |
| Company DUNS | 029957656 |
| Company Name | MOBERG RESEARCH 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B485VIS100 [Primary] |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-11-05 |
| Device Publish Date | 2020-10-28 |
| B485CNSPTZ3501 - Component Monitoring System | 2021-04-27 Optional camera that can be used to record video of the patient. |
| B485CNS3501 - Component Neuromonitoring System | 2021-02-22 A portable, computer-based system that can continuously record, display, store and analyze physiological data from multiple moni |
| B485CNSVID3501 - Component Monitoring System | 2020-11-09 Domestic model; optional camera that can be used to record video of the patient. |
| B485VIS100 - CNS Envision | 2020-11-05Software for use in the review, annotation and analysis of patient data collected using external physiological monitors. |
| B485VIS100 - CNS Envision | 2020-11-05 Software for use in the review, annotation and analysis of patient data collected using external physiological monitors. |
| B485CNSVID3701 - Component Monitoring System | 2020-11-02 International model; optional camera that can be used to record video of the patient. |
| B485CNSPTZ3001 - Component Neuromonitoring System | 2019-04-01 Domestic (U.S.) model; optional camera that can be used to record video of the patient. |
| B485CNSPTZ3101 - Component Neuromonitoring System | 2019-04-01 Research model; optional camera that can be used to record video of the patient. |
| B485CNSINX3001 - Component Neuromonitoring System | 2018-07-09 Domestic (U.S.) model; 4 port isolated USB serial adapter |