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

    INFRA-EYE 160

    K Number: K841271 · Decision Jul 28, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    40
    Applicant Total
    1
    Review Days
    123

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    Basic Information

    Device Name
    INFRA-EYE 160
    K Number
    K841271
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.2980
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Fujitsu , Ltd.
    Date Received
    March 27, 1984
    Decision Date
    July 28, 1984
    Product Code
    LHQ
    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
    LHQ System, Telethermographic (Adjunctive Use)

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