BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    EQUASHIELD SYSTEM PROTECTIVE PLUS

    K Number: K101940 · Decision Nov 19, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    205
    Applicant Total
    5
    Review Days
    130

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    Basic Information

    Device Name
    EQUASHIELD SYSTEM PROTECTIVE PLUS
    K Number
    K101940
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Equashield Medical , Ltd.
    Date Received
    July 12, 2010
    Decision Date
    November 19, 2010
    Product Code
    LHI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LHI Set, I.V. Fluid Transfer

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    Other Clearances by Equashield Medical , Ltd.

    K Number Device Name
    K221513 Equashield Closed System Transfer Device
    K170706 Equashield Closed System drug Transfer Device (CSTD)
    K150219 Equashield Closed System drug Transfer Device (CSTD)
    K132899 EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD)