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

    SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)

    K Number: K241348 · Decision Jan 31, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    49
    Applicant Total
    2
    Review Days
    263

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    Basic Information

    Device Name
    SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)
    K Number
    K241348
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Motilitycount Aps
    Date Received
    May 13, 2024
    Decision Date
    January 31, 2025
    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 Motilitycount Aps

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