BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    YO Home Sperm Test

    K Number: K241628 · Decision Nov 29, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    27
    Applicant Total
    5
    Review Days
    176

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    Basic Information

    Device Name
    YO Home Sperm Test
    K Number
    K241628
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Electronic Systems , Ltd.
    Date Received
    June 6, 2024
    Decision Date
    November 29, 2024
    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 Medical Electronic Systems , Ltd.

    K Number Device Name
    K243114 SQA-iOw Sperm Quality Analyzer
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    K161493 YO Home Sperm Test
    K063864 QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS