Product code
QLS: Pulse oximeter for low-acuity settings
FDA product code · Class II · Anesthesiology
Key facts
| Product code | QLS |
|---|---|
| Device | Pulse oximeter for low-acuity settings |
| Device class | Class II |
| Regulation number | 870.2700 |
| Review panel | Anesthesiology |
| Medical specialty | Cardiovascular |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Pulse oximeter intended for low-acuity settings. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None 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