FDA Device Establishments · JSON-LD · Markdown
FEI 3011648943 · Manufacture Medical Device · Status: Active
| FEI Number | 3011648943 |
|---|---|
| Owner / Operator | Healcerion Co., Ltd. (#10049969) |
| Address | 1013-Ho, 12 Digital-Ro 33-Gil, Guro-Gu, Seoul, 08377, KR |
| Mandatory US Agent | Provision Consulting Group, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 3 |
| Product codes (top 20) | ITX, IYN, IYO |
| Regulation § (21 CFR) | 892.1570, 892.1550, 892.1560 |
| Proprietary names | SONON Ultrasound Imaging System (Model: SONON 500L) |
Source: openFDA. Public-domain (CC0).