Product code
LIX: Aid, cardiopulmonary resuscitation
FDA product code · Class II · Cardiovascular
Key facts
| Product code | LIX |
|---|---|
| Device | Aid, cardiopulmonary resuscitation |
| Device class | Class II |
| Regulation number | 870.5210 |
| Review panel | Cardiovascular |
| Medical specialty | Cardiovascular |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | CPR Aid device WITH feedback (visual, audio or both) on one or more CPR parameters (e.g., rate, depth, ventilation ratio, etc.), and contains software. Provides real-time feedback on CPR performance. Feedback can be audio, visual or both. Device contains software |
At a glance
- 10–99 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 100–999 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