FDA Device Establishments · JSON-LD · Markdown
FEI 3010102386 · Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active
| FEI Number | 3010102386 |
|---|---|
| Owner / Operator | Butterfly Network, Inc. (#10057531) |
| Address | 1600 District Ave, Burlington, MA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 4 |
| Product codes (top 20) | IYO, QIH, IYN, ITX |
| Regulation § (21 CFR) | 892.1560, 892.2050, 892.1550, 892.1570 |
| Proprietary names | Butterfly iQ3 Ultrasound System |
Source: openFDA. Public-domain (CC0).