BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Eko Core Digital Stethoscope

    DI: 00850010298016 · Model: E6 · Eko Devices, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Eko Core Digital Stethoscope
    Primary DI
    00850010298016
    Version / Model
    E6
    Company Name
    Eko Devices, Inc.
    Labeler DUNS
    079670921
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-11-01
    Public Version
    5
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    ffd48247-9d74-4083-a373-4f6b8fad385b

    Device Description

    The Eko Core Electronic Stethoscope is a complete electronic stethoscope with digital & analog capabilities that wirelessly pairs to the free Eko Mobile App for recording, visualization, sharing, and annotation of sounds.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DQD Stethoscope, Electronic

    GMDN Terms

    Code Name
    13754 Electronic stethoscope

    Identifiers

    Type ID
    Primary 00850010298016

    Premarket Submissions

    Submission Number Supplement Number
    K151319 000