FDA Device Establishments · JSON-LD · Markdown

CARDIAC INSIGHT, INC.

FEI 3010342616 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active

FEI Number3010342616
Owner / OperatorCardiac Insight, Inc. (#10044470)
Address2375 130th Ave NE, Suite 101, Bellevue, WA, US
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)DPS
Regulation § (21 CFR)870.2340
Proprietary namesCardeaScreen; Cardea 20/20 ECG; MedicECG

External sources

Source: openFDA. Public-domain (CC0).