FDA Device Establishments · JSON-LD · Markdown
FEI 3015185344 · Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3015185344 |
|---|---|
| Owner / Operator | Kestra Medical (#10082485) |
| Address | 3933 Lake Washington Blvd, NE, Kirkland, WA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | DXH, MWJ |
| Regulation § (21 CFR) | 870.2920, 870.2800 |
| Proprietary names | ASSURE Wearable ECG |
Source: openFDA. Public-domain (CC0).