BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Trak Plus Male Fertility Testing System

    K Number: K172514 · Decision Nov 17, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    27
    Applicant Total
    2
    Review Days
    88

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    Basic Information

    Device Name
    Trak Plus Male Fertility Testing System
    K Number
    K172514
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sandstone Diagnostics, Inc.
    Date Received
    August 21, 2017
    Decision Date
    November 17, 2017
    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 Sandstone Diagnostics, Inc.

    K Number Device Name
    K153683 Trak Male Fertility Testing System