BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇳 India

    STAR 65

    K Number: K172147 · Decision May 25, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    2
    Review Days
    312

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    Basic Information

    Device Name
    STAR 65
    K Number
    K172147
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Skanray Technologies Pvt, Ltd.
    Date Received
    July 17, 2017
    Decision Date
    May 25, 2018
    Product Code
    MWI
    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
    MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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    Other Clearances by Skanray Technologies Pvt, Ltd.

    K Number Device Name
    K150512 STAR 90