BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MoMe Kardia

    Reg #: 3010112812 · FEI: 3010112812 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    INFOBIONIC, INC.
    Registration Number
    3010112812
    FEI Number
    3010112812
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    321 Billerica Rd, Office Link #5
    City
    Chelmsford
    State
    MA
    ZIP
    01824
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160064

    Owner / Operator

    Firm Name
    InfoBionic, Inc.
    Operator Number
    10051518
    Address
    321 Billerica Rd, Office Link #5
    City
    Chelmsford
    State
    MA
    Postal Code
    01824
    Country
    US
    Correspondent
    Dave MacCutcheon

    Products

    Device Name Product Code
    Detector And Alarm, Arrhythmia DSI
    Outpatient Cardiac Telemetry QYX

    Proprietary Names

    MoMe Kardia

    Establishment Types

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