FDA Device Establishments · JSON-LD · Markdown
FEI 3013300026 · Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3013300026 |
|---|---|
| Owner / Operator | BIOSENSE WEBSTER, INC. (#9044811) |
| Address | 31 Technology Drive, Suite 200, --, Irvine, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 1 |
| Product codes (top 20) | DQK |
| Regulation § (21 CFR) | 870.1425 |
| Proprietary names | CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) |
Source: openFDA. Public-domain (CC0).