Product code
HEO: Analyzer, data, obstetric
FDA product code · Class III · Obstetrics/Gynecology
Key facts
| Product code | HEO |
|---|---|
| Device | Analyzer, data, obstetric |
| Device class | Class III |
| Regulation number | 884.2050 |
| Review panel | Obstetrics/Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Call for PMAs to be filed by 10/3/00 per 65 FR 41332 on 7/5/00 |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- 10–99 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