FDA Device Establishments · JSON-LD · Markdown
FEI 3012411160 · Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3012411160 |
|---|---|
| Owner / Operator | Probo Medical, Inc. (#10051673) |
| Address | 9715 Kincaid Dr Ste 1000, Fishers, IN, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 3 |
| Product codes (top 20) | IYN, ITX, IYO |
| Regulation § (21 CFR) | 892.1550, 892.1570, 892.1560 |
| Proprietary names | M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9Premium Diagnostic Ultrasound System |
Source: openFDA. Public-domain (CC0).