Product code
MKJ: Automated external defibrillators (non-wearable)
FDA product code · Class III · Cardiovascular
Key facts
| Product code | MKJ |
|---|---|
| Device | Automated external defibrillators (non-wearable) |
| Device class | Class III |
| Regulation number | 870.5310 |
| Review panel | Cardiovascular |
| Medical specialty | Cardiovascular |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is… |
At a glance
- 100–999 510(k) clearances
- None De Novo grants
- 10–99 PMA approvals
- None HDE approvals
- 1,000+ UDI devices (GUDID)
- 1,000+ MAUDE adverse event reports
- 100–999 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