BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    NUNC IVF MULTIDISH 4 WELLS NUNCLON

    K Number: K040717 · Decision Aug 12, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    49
    Applicant Total
    2
    Review Days
    146

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    Basic Information

    Device Name
    NUNC IVF MULTIDISH 4 WELLS NUNCLON
    K Number
    K040717
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nunc A/S
    Date Received
    March 19, 2004
    Decision Date
    August 12, 2004
    Product Code
    MQK
    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
    MQK Labware, Assisted Reproduction

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    Other Clearances by Nunc A/S

    K Number Device Name
    K070047 NUNC IVF DISHES AND NUNC IVF 4-WELL DISH