FDA Device Establishments · JSON-LD · Markdown
FEI 3007382160 · Manufacture Medical Device · Status: Active
| FEI Number | 3007382160 |
|---|---|
| Owner / Operator | i-SENS, Inc. (#9083763) |
| Address | 94-1, Donghwagongdan-ro, Munmak-eup, Wonju-si Gangwon, 26365, KR |
| Mandatory US Agent | i-SENS USA, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | JIN |
| Regulation § (21 CFR) | 862.1435 |
| Proprietary names | KetoSens BT Blood ?-Ketone Monitoring System |
Source: openFDA. Public-domain (CC0).