BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Clue Birth Control

    K Number: K193330 · Decision Feb 18, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    444

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    Basic Information

    Device Name
    Clue Birth Control
    K Number
    K193330
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    884.5370
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biowink GmbH
    Date Received
    December 2, 2019
    Decision Date
    February 18, 2021
    Product Code
    PYT
    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
    PYT Device, Fertility Diagnostic, Contraceptive, Software Application

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