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

    CRITICOOL

    K Number: K083662 · Decision Mar 26, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    157
    Applicant Total
    6
    Review Days
    106

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    Basic Information

    Device Name
    CRITICOOL
    K Number
    K083662
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mtre Advanced Technology , Ltd.
    Date Received
    December 10, 2008
    Decision Date
    March 26, 2009
    Product Code
    DWJ
    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
    DWJ System, Thermal Regulating

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    Other Clearances by Mtre Advanced Technology , Ltd.

    K Number Device Name
    K102112 CRITICOOL PRO
    K024128 ALLON 2001 VERSION 5
    K003349 ALLON 2001 MODIFIED
    K001546 ALLON 2001
    K992386 ALLON 2000