FDA Device Establishments · JSON-LD · Markdown

Esaote North America, Inc

FEI 1826555 · Complaint File Establishment per 21 CFR 820.198 · Status: Active

FEI Number1826555
Owner / OperatorESAOTE S.P.A. (#8021005)
Address11907 Exit Five Parkway, Fishers, IN, US
Registration expiry2026
Initial importer flagY
Registered products3
Product codes (top 20)IYN, IYO, ITX
Regulation § (21 CFR)892.1550, 892.1560, 892.1570
Proprietary namesMyLabX75; 6430 US System

External sources

Source: openFDA. Public-domain (CC0).