BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BREAST THERMAL ACTIVITY INDICATOR

    K Number: K832989 · Decision Jan 17, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    138

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    Basic Information

    Device Name
    BREAST THERMAL ACTIVITY INDICATOR
    K Number
    K832989
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.2982
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Bcsi Laboratories, Inc.
    Date Received
    September 1, 1983
    Decision Date
    January 17, 1984
    Product Code
    KYA
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KYA System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)

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