Avive Automated External Defibrillator (AED) System is an AI-enabled medical device from Avive Solutions, Inc., listed by FDA (PMA, P210015) with a decision date of 2022-10-31. Review panel: Cardiovascular.
| FDA submission number | P210015 |
|---|---|
| Pathway | PMA |
| Company | Avive Solutions, Inc. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2022-10-31 |
| Product code | MKJ |
| Classification | Automated External Defibrillators (Non-Wearable) |
| Device class | 3 |
| Regulation number | 870.5310 |
| Review time (calendar days) | 573 |
Official FDA database record · FDA AI-enabled device list
All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.