Product code
PDR: Computer-assisted personalized sedation system
FDA product code · Class III · Anesthesiology
Key facts
| Product code | PDR |
|---|---|
| Device | Computer-assisted personalized sedation system |
| Device class | Class III |
| Review panel | Anesthesiology |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Computer assisted system to administer a drug and control depth of sedation and provide monitoring and alarms for physiological vital signs and other parameters of sedation. |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- 1–9 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