FDA Device Establishments · JSON-LD · Markdown
FEI 3035371769 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active
| FEI Number | 3035371769 |
|---|---|
| Owner / Operator | HeartBeam (#10092613) |
| Address | 2118 Walsh Ave Ste 210, Santa Clara, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | MWJ |
| Regulation § (21 CFR) | 870.2800 |
| Proprietary names | HeartBeam AIMIGo System; HeartBeam System |
Source: openFDA. Public-domain (CC0).