FDA Device Establishments · JSON-LD · Markdown
FEI 3009715978 · Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3009715978 |
|---|---|
| Owner / Operator | AliveCor, Inc. (#10041430) |
| Address | 189 N Bernardo Avenue, Suite 100, Mountain View, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 3 |
| Product codes (top 20) | QDA, DXH, DPS |
| Regulation § (21 CFR) | 870.2345, 870.2920, 870.2340 |
| Proprietary names | Kardia 6L+; KardiaMobile 6L Max; KARDIAMOBILE 6L; K1000 |
Source: openFDA. Public-domain (CC0).