BEUDAMED
    FDA Registration Active 🇺🇸 United States

    The Guardian System

    Reg #: 3017374019 · FEI: 3017374019 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    AVERTIX MEDICAL INC.
    Registration Number
    3017374019
    FEI Number
    3017374019
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    40 Christopher Way, Suite 201
    City
    Eatontown
    State
    NJ
    ZIP
    07724
    Country
    US

    Regulatory Submissions

    PMA Number
    P150009

    Owner / Operator

    Firm Name
    Avertix Medical Inc.
    Operator Number
    10079576
    Address
    40 Christopher Way, Suite 201
    City
    Eatontown
    State
    NJ
    Postal Code
    07724
    Country
    US
    Correspondent
    David L Keenan

    Products

    Device Name Product Code
    Acute Coronary Syndrome Event Detector QBI

    Proprietary Names

    The Guardian System

    Establishment Types

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