BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇭 Switzerland

    Ava Fertility Tracker

    K Number: K200163 · Decision Jan 19, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    363

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    Basic Information

    Device Name
    Ava Fertility Tracker
    K Number
    K200163
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ava AG
    Date Received
    January 22, 2020
    Decision Date
    January 19, 2021
    Product Code
    LHD
    Advisory Committee
    Unknown
    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
    LHD Device, Fertility Diagnostic, Proceptive

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