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

    REMOTE PRESENCE SYSTEM

    K Number: K120895 · Decision May 24, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    188
    Applicant Total
    2
    Review Days
    62

    Basic Information

    Device Name
    REMOTE PRESENCE SYSTEM
    K Number
    K120895
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2910
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    INTOUCH HEALTH, INC.
    Date Received
    March 23, 2012
    Decision Date
    May 24, 2012
    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 INTOUCH HEALTH, INC.

    K Number Device Name
    K123229 REMOTE PRESENCE SYSTEM, MODEL RP-VITA