Product code
OPT: Infrared hematoma detector
FDA product code · Class II · Neurology
Key facts
| Product code | OPT |
|---|---|
| Device | Infrared hematoma detector |
| Device class | Class II |
| Regulation number | 882.1935 |
| Review panel | Neurology |
| Medical specialty | Ophthalmic |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas. |
At a glance
- 1–9 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 1–9 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