FDA Device Establishments · JSON-LD · Markdown
FEI 3017654247 · Manufacture Medical Device · Status: Active
| FEI Number | 3017654247 |
|---|---|
| Owner / Operator | SpectraWAVE, Inc. (#10084575) |
| Address | 12 Oak Park Drive, Bedford, MA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 4 |
| Product codes (top 20) | NQQ, ORD, IYO, OGZ |
| Regulation § (21 CFR) | 892.1560, 870.1200 |
| Proprietary names | Starlight Imaging Catheter; HyperVue Imaging System |
Source: openFDA. Public-domain (CC0).