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

    SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1

    K Number: K000623 · Decision May 16, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    258
    Applicant Total
    7
    Review Days
    89

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    Basic Information

    Device Name
    SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1
    K Number
    K000623
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6180
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vitrolife AB/Scandinavian Ivf Sciences AB
    Date Received
    February 17, 2000
    Decision Date
    May 16, 2000
    Product Code
    MQL
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MQL Media, Reproductive

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    Other Clearances by Vitrolife AB/Scandinavian Ivf Sciences AB

    K Number Device Name
    K000619 SCANDINAVIAN IVF SCIENCES AB, G2.2
    K000627 SCANDINAVIAN IVF SCIENCES AB, HYBASE-1
    K000626 SCANDINAVIAN IVF SCIENCES AB, GAMETE-100
    K000625 SCANDINAVIAN IVF SCIENCES AB, G1.2
    K000618 SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1
    K000621 SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100