Product code
ONV: Electrical impedance spectrometer
FDA product code · Class III · General & Plastic Surgery
Key facts
| Product code | ONV |
|---|---|
| Device | Electrical impedance spectrometer |
| Device class | Class III |
| Review panel | General & Plastic Surgery |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | It is indicated for use on cutaneous lesions with one or more clinical or historical characteristics of melanoma, when a dermatologist chooses to obtain additional information when considering biopsy. It should not be used on clinically obvious melanoma. It is to be used as one element of the overall clinical assessment. The output given by the device should be used in combination with clinical… |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 1–9 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