Product code
PHV: Continuous glucose monitor retrospective data analysis software
FDA product code · Class I · Clinical Chemistry
Key facts
| Product code | PHV |
|---|---|
| Device | Continuous glucose monitor retrospective data analysis software |
| Device class | Class I |
| Regulation number | 862.2120 |
| Review panel | Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Continuous glucose monitor retrospective data analysis software is intended to analyze and correlate retrospective data from a continuous glucose monitoring device. |
At a glance
- None 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 1,000+ 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