BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer

    K Number: K180343 · Decision Nov 16, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    27
    Applicant Total
    5
    Review Days
    282

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    Basic Information

    Device Name
    LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer
    K Number
    K180343
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bonraybio Co., Ltd.
    Date Received
    February 7, 2018
    Decision Date
    November 16, 2018
    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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