SENSICARDIAC is an AI-enabled medical device from DIACOUSTIC MEDICAL (PTY), listed by FDA (510(k), K121617) with a decision date of 2012-07-27. Review panel: Cardiovascular.
| FDA submission number | K121617 |
|---|---|
| Pathway | 510(k) |
| Company | DIACOUSTIC MEDICAL (PTY) |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2012-07-27 |
| Decision | Substantially Equivalent |
| Product code | DQD |
| Classification | Stethoscope, Electronic |
| Device class | 2 |
| Regulation number | 870.1875 |
| Review time (calendar days) | 56 |
| 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.