| Primary Device ID | 00869732000128 |
| NIH Device Record Key | 15381ad2-5ba8-4f5e-8c90-14a425de47f8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Persyst 14 Review and Analysis Software |
| Version Model Number | P14 |
| Company DUNS | 024168209 |
| 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00869732000128 [Primary] |
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-07-12 |
| Device Publish Date | 2019-04-08 |
| 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 | 2019-07-12Persyst 14 is a quantitative EEG trending, spike and seizure detection software. Persyst 14 is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings. |
| 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 |