FDA Device Establishments · JSON-LD · Markdown
FEI 3027256461 · Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3027256461 |
|---|---|
| Owner / Operator | MASIMO CORPORATION (#9031881) |
| Address | Lot 198511 (PLO 547-A) & Lot 198512 (PLO 547-B), Jalan Keluli 11, Zon 12A Kawasan Perindustrian Pasir Gudang, Pasir Gudang Johor, 81700, MY |
| Mandatory US Agent | MASIMO CORPORATION |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | DQA |
| Regulation § (21 CFR) | 870.2700 |
| Proprietary names | M-LNCS YI; LNCS YI |
Source: openFDA. Public-domain (CC0).