BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    INSULIN PROTECTOR

    K Number: K073555 · Decision Jul 11, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    206

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    Basic Information

    Device Name
    INSULIN PROTECTOR
    K Number
    K073555
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5050
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medicool, Inc.
    Date Received
    December 18, 2007
    Decision Date
    July 11, 2008
    Product Code
    IQG
    Advisory Committee
    Physical Medicine
    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
    IQG Adaptor, Holder, Syringe

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IQG), ordered by most recent decision date.

    INSUCOZI INSULIN VIAL COVER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ISECURE SYRINGE CARTRIDGE HOLDER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine
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    Other Clearances by Medicool, Inc.

    K Number Device Name
    K895674 MEDICOOL, CONTAINER FOR STORING INSULIN