FDA Device Establishments · JSON-LD · Markdown
FEI 3015478020 · Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3015478020 |
|---|---|
| Owner / Operator | Optellum Ltd (#10060418) |
| Address | Five Kings Meadow, Osney Mead, Oxford Oxfordshire, OX2 0DP, GB |
| Mandatory US Agent | Registrar Corp |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | POK |
| Regulation § (21 CFR) | 892.2060 |
| Proprietary names | Optellum platform; Optellum software; Optellum Virtual Nodule Clinic |
Source: openFDA. Public-domain (CC0).