Product code
NHM: Sheet, recording, breast examination
FDA product code · Class II · Obstetrics/Gynecology
Key facts
| Product code | NHM |
|---|---|
| Device | Sheet, recording, breast examination |
| Device class | Class II |
| Regulation number | 884.2990 |
| Review panel | Obstetrics/Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | This recording sheet is intended to for clinicians to mark the locationof a palpable breast lump identified by a clinical breast examination. |
At a glance
- 1–9 510(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