FDA Device Establishments · JSON-LD · Markdown
FEI 3019216 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3019216 |
|---|---|
| Owner / Operator | Philips Medical Systems International BV (#1217116) |
| Address | 22100 Bothell Everett Hwy, BOTHELL, WA, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 3 |
| Product codes (top 20) | ITX, IYN, IYO |
| Regulation § (21 CFR) | 892.1570, 892.1550, 892.1560 |
| Proprietary names | X7-2t; C10-3v; S8-3; EPIQ 5W Diagnostic Ultrasound System; eL18-4; V6-2; Affiniti 70W Diagnostic Ultrasound System; EPIQ 7G Diagnostic Ultrasound System; S7-3t; Affiniti 50W Diagnostic Ultrasound System |
Source: openFDA. Public-domain (CC0).