FDA Device Establishments · JSON-LD · Markdown
FEI 3014310698 · Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active
| FEI Number | 3014310698 |
|---|---|
| Owner / Operator | Hyperfine, Inc. (#10077154) |
| Address | 351 New Whitfield Street, Guilford, CT, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | IWY |
| Regulation § (21 CFR) | 892.1920 |
| Proprietary names | Foam Had Pad; Head Stabilizer |
Source: openFDA. Public-domain (CC0).