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

    ALLON 2001

    K Number: K001546 · Decision Jun 8, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    157
    Applicant Total
    6
    Review Days
    21

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    Basic Information

    Device Name
    ALLON 2001
    K Number
    K001546
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mtre Advanced Technology , Ltd.
    Date Received
    May 18, 2000
    Decision Date
    June 8, 2000
    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
    K083662 CRITICOOL
    K024128 ALLON 2001 VERSION 5
    K003349 ALLON 2001 MODIFIED
    K992386 ALLON 2000