BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HEARTBEAM

    Reg #: 3035371769 · FEI: 3035371769 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    3

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    Registration Details

    Registration Name
    HEARTBEAM
    Registration Number
    3035371769
    FEI Number
    3035371769
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2118 Walsh Ave Ste 210
    City
    Santa Clara
    State
    CA
    ZIP
    95050
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231424

    Owner / Operator

    Firm Name
    HeartBeam
    Operator Number
    10092613
    Address
    2118 Walsh Road, Suite 210
    City
    Santa Clara
    State
    CA
    Postal Code
    95050
    Country
    US
    Correspondent
    Deborah Castillo

    Products

    Device Name Product Code
    Electrocardiograph, Ambulatory (Without Analysis) MWJ
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Electrocardiograph DPS

    Proprietary Names

    HeartBeam System HeartBeam AIMIGo System HeartBeam with 12-L ECG Synthesis Software System

    Establishment Types

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