| Primary Device ID | 00869732000166 |
| NIH Device Record Key | c8ce9b05-4205-4d01-b8a1-53c05f161a52 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Persyst 15 EEG Review and Analysis Software |
| Version Model Number | P15 |
| Company DUNS | 159514244 |
| Company Name | Persyst Development Corp |
| 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 | 9287080705 |
| support@persyst.com | |
| Phone | 9287080705 |
| support@persyst.com | |
| Phone | 9287080705 |
| support@persyst.com | |
| Phone | 9287080705 |
| support@persyst.com | |
| Phone | 9287080705 |
| support@persyst.com | |
| Phone | 9287080705 |
| support@persyst.com | |
| Phone | 9287080705 |
| support@persyst.com | |
| Phone | 9287080705 |
| support@persyst.com | |
| Phone | 9287080705 |
| support@persyst.com | |
| Phone | 9287080705 |
| support@persyst.com | |
| Phone | 9287080705 |
| support@persyst.com | |
| Phone | 9287080705 |
| support@persyst.com | |
| Phone | 9287080705 |
| support@persyst.com | |
| Phone | 9287080705 |
| support@persyst.com | |
| Phone | 9287080705 |
| support@persyst.com | |
| Phone | 9287080705 |
| support@persyst.com | |
| Phone | 9287080705 |
| support@persyst.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00869732000166 [Primary] |
| OMB | Automatic Event Detection Software For Full-Montage 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 | 2023-08-01 |
| Device Publish Date | 2023-07-24 |
| 00869732000166 - Persyst 15 EEG Review and Analysis Software | 2023-08-01Persyst 15 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information. |
| 00869732000166 - Persyst 15 EEG Review and Analysis Software | 2023-08-01 Persyst 15 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electr |
| 00869732000128 - Persyst 14 Review and Analysis Software | 2019-07-12 Persyst 14 is a quantitative EEG trending, spike and seizure detection software. Persyst 14 is used for both monitoring and tren |
| 00869732000135 - Persyst Mobile App | 2019-07-12 This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system p |
| 00869732000142 - Persyst Mobile App | 2019-07-12 This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system p |
| 00869732000104 - Persyst 12 EEG Review and Analysis Software | 2019-07-12 Persyst 12 is a quantitative EEG trending, spike and seizure detection software. Persyst 12 is used for both monitoring and tren |
| 00869732000111 - Persyst 13 EEG Review and Analysis Software | 2019-07-12 Persyst 13 is a quantitative EEG trending, spike and seizure detection software. Persyst 13 is used for both monitoring and tren |