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

    SwimCount Sperm Quality Test

    K Number: K183602 · Decision Jun 27, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    27
    Applicant Total
    2
    Review Days
    183

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    Basic Information

    Device Name
    SwimCount Sperm Quality Test
    K Number
    K183602
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Motilitycount Aps
    Date Received
    December 26, 2018
    Decision Date
    June 27, 2019
    Product Code
    POV
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    POV Semen Analysis Device

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    Other Clearances by Motilitycount Aps

    K Number Device Name
    K241348 SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)