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

    CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION

    K Number: K130360 · Decision Jul 15, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    190
    Applicant Total
    2
    Review Days
    152

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    Basic Information

    Device Name
    CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION
    K Number
    K130360
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2910
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Constant Care, LLC
    Date Received
    February 13, 2013
    Decision Date
    July 15, 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

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    Other Clearances by Constant Care, LLC

    K Number Device Name
    K120941 CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM