FDA Device Establishments · JSON-LD · Markdown
FEI 3042585081 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3042585081 |
|---|---|
| Owner / Operator | iSono Health Inc. (#10095119) |
| Address | 538 Oakmead Pkwy, Sunnyvale, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | IYO, ITX |
| Regulation § (21 CFR) | 892.1560, 892.1570 |
| Proprietary names | ATUSA |
Source: openFDA. Public-domain (CC0).