Product code
QME: Software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate
FDA product code · Class II · Cardiovascular
Key facts
| Product code | QME |
|---|---|
| Device | Software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate |
| Device class | Class II |
| Regulation number | 870.2785 |
| Review panel | Cardiovascular |
| Medical specialty | Cardiovascular |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy. |
At a glance
- 10–99 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database