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

    MEDIC4ALL TELEMEDICINE SYSTEM VMS-01

    K Number: K061502 · Decision Sep 15, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    188
    Applicant Total
    3
    Review Days
    107

    Basic Information

    Device Name
    MEDIC4ALL TELEMEDICINE SYSTEM VMS-01
    K Number
    K061502
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2910
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MEDIC4ALL (ISRAEL) LTD.
    Date Received
    May 31, 2006
    Decision Date
    September 15, 2006
    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 MEDIC4ALL (ISRAEL) LTD.

    K Number Device Name
    K062662 TELEMEDICINE SYSTEM MODEL VMS-01
    K062127 MEDIC4ALL TELEMEDICINE SYSTEM, MODEL VMS-01 (NIBP)