FDA Device Establishments · JSON-LD · Markdown
FEI 3017552925 · Manufacture Medical Device · Status: Active
| FEI Number | 3017552925 |
|---|---|
| Owner / Operator | Outset Medical, Inc. (#10047467) |
| Address | C. Vecinal #20601, Modulos J y K Col. Presa Rodriguez, Tijuana Baja California, C.P. 22124, MX |
| Mandatory US Agent | Outset Medical, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | KDI, FIP |
| Regulation § (21 CFR) | 876.5860, 876.5665 |
| Proprietary names | Tablo® Hemodialysis System |
Source: openFDA. Public-domain (CC0).