FDA Device Establishments · JSON-LD · Markdown
FEI 3003990090 · Manufacture Medical Device · Status: Active
| FEI Number | 3003990090 |
|---|---|
| Owner / Operator | Caldera Medical (#10028052) |
| Address | 4360 Park Terrace Drive, Westlake Village, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | FAJ, HIH |
| Regulation § (21 CFR) | 876.1500, 884.1690 |
| Proprietary names | LUMINELLE DTx Hysteroscopy System |
Source: openFDA. Public-domain (CC0).