BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Eko Health, Inc.

    Reg #: 3011651230 · FEI: 3011651230 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    8
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    Eko Health, Inc.
    Registration Number
    3011651230
    FEI Number
    3011651230
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2100 Powell St, Suite 300
    City
    Emeryville
    State
    CA
    ZIP
    94608
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230111

    Owner / Operator

    Firm Name
    Eko Health, Inc.
    Operator Number
    10049275
    Address
    2100 Powell St, Suite 300
    City
    Emeryville
    State
    CA
    Postal Code
    94608
    Country
    US
    Correspondent
    Connor Landgraf

    Products

    Device Name Product Code
    Stethoscope, Electronic DQD
    Electrocardiograph DPS
    Phonocardiograph DQC
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Reduced Ejection Fraction Machine Learning-Based Notification Software QYE

    Proprietary Names

    CORE 500 Digital Stethoscope SENSORA Eko Foundation Analysis Software with Transformers (EFAST) Eko Analysis Software Eko CORE 3M™ Littmann® CORE Digital Stethoscope Eko Electronic Stethoscope System Eko Low Ejection Fraction Tool (ELEFT)

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility