VISENSIA is an AI-enabled medical device from OBS MEDICAL, listed by FDA (510(k), K081140) with a decision date of 2008-07-17. Review panel: Cardiovascular.
| FDA submission number | K081140 |
|---|---|
| Pathway | 510(k) |
| Company | OBS MEDICAL |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2008-07-17 |
| Decision | Substantially Equivalent |
| Product code | MHX |
| Classification | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | 2 |
| Regulation number | 870.1025 |
| Review time (calendar days) | 86 |
| Applicant country | US |
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.