Product code
OEY: Single lead over-the-counter electrocardiograph
FDA product code · Class II · Cardiovascular
Key facts
| Product code | OEY |
|---|---|
| Device | Single lead over-the-counter electrocardiograph |
| Device class | Class II |
| Regulation number | 870.2340 |
| Review panel | Cardiovascular |
| Medical specialty | Cardiovascular |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Devices are intended to record and analyze single-lead electrocardiograms. Devices only display interval values to the user. Devices are intended for over-the-counter sale. Devices are indicated for users who wish to monitor common ECG intervals. |
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