BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RhythmStar

    Reg #: 3011265784 · FEI: 3011265784 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Rhythmedix
    Registration Number
    3011265784
    FEI Number
    3011265784
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Horizon Corporate Center, 5000 Atrium Way, Suite 1
    City
    Mount Laurel
    State
    NJ
    ZIP
    08054
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141813

    Owner / Operator

    Firm Name
    Rhythmedix
    Operator Number
    10047405
    Address
    Horizon Corporate Center, 5000 Atrium Way, Suite 1
    City
    Mount Laurel
    State
    NJ
    Postal Code
    08054
    Country
    US
    Correspondent
    Stan Biletsky

    Products

    Device Name Product Code
    Transmitters And Receivers, Electrocardiograph, Telephone DXH

    Proprietary Names

    RhythmStar BodyGuardian ONE

    Establishment Types

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