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

    SYMPTOTHERM 8 FERTILITY INDICATOR

    K Number: K821507 · Decision Oct 14, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    147

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    Basic Information

    Device Name
    SYMPTOTHERM 8 FERTILITY INDICATOR
    K Number
    K821507
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Ovix Corp., Inc.
    Date Received
    May 20, 1982
    Decision Date
    October 14, 1982
    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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