FDA Device Establishments · JSON-LD · Markdown
FEI 3038790635 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3038790635 |
|---|---|
| Owner / Operator | Optain Health (#10093665) |
| Address | 526 S Main St Ste 211, Akron, OH, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | HKI |
| Regulation § (21 CFR) | 886.1120 |
| Proprietary names | Optain Resolve Fundus Camera |
Source: openFDA. Public-domain (CC0).