BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AMBIO REMOTE HEALTH MONITORING SYSTEM

    K Number: K130676 · Decision Jul 8, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    190
    Applicant Total
    1
    Review Days
    118

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    AMBIO REMOTE HEALTH MONITORING SYSTEM
    K Number
    K130676
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2910
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arrayent Health, LLC D/B/A Ambio Health
    Date Received
    March 12, 2013
    Decision Date
    July 8, 2013
    Product Code
    DRG
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DRG), ordered by most recent decision date.

    Perin Health System (PHD80060-2)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EasyTeleMed (2.0.2)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TeleRehab Aermos Cardiopulmonary Rehabilitation

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    iBSM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UbiqVue™ 2A Multi-parameter System (UX2550)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BioButton System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all