FDA Device Establishments · JSON-LD · Markdown
FEI 3014541700 · Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3014541700 |
|---|---|
| Owner / Operator | Philips Medical Systems International BV (#1217116) |
| Address | Avenida Otto Selgado, 250, Varginha Minas Gerais, CEP 37066, BR |
| Mandatory US Agent | PHILIPS |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 20 |
| Product codes (top 20) | DSF, DRS, HFM, DSA, DSI, DSK, DQA, DXN, DSJ, DRT, FLL, DXQ, JOM, HGL, DRG, DRQ, DXG, HFN, MSX, HGM |
| Regulation § (21 CFR) | 870.2810, 870.2850, 884.2720, 870.2900, 870.1025, 870.1110, 870.2700, 870.1130, 870.1100, 870.2300 |
| Proprietary names | Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A); Avalon Fetal & Maternal Patch; Avalon Patient Module (M2738A); Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA); Avalon Basestation (866074); M1911A Fetal Monitoring Recording Paper; MECG Adapter Cable (M1363A); M1910A Fetal Monitoring Recording Paper; Avalon CL Fetal & Maternal Pod (866488); M2734B |
Source: openFDA. Public-domain (CC0).