FaceHeart Vitals Software Development Kit (FH vitals SDK) is an AI-enabled medical device from FaceHeart Corp., listed by FDA (510(k), K223622) with a decision date of 2023-09-01. Review panel: Cardiovascular.
| FDA submission number | K223622 |
|---|---|
| Pathway | 510(k) |
| Company | FaceHeart Corp. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2023-09-01 |
| Decision | Substantially Equivalent |
| Product code | QME |
| Classification | Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate |
| Device class | 2 |
| Regulation number | 870.2785 |
| Review time (calendar days) | 270 |
| Applicant country | KY |
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.